%%EOF We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream Do not use ozone or ultraviolet (UV) light cleaners. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. You are about to visit the Philips USA website. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Then you can register your product. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Images may vary. Our Prescription Team is required to review all prescriptions. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. To register a new purchase, please have the product on hand and log into your My Philips account. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . The .gov means its official.Federal government websites often end in .gov or .mil. Well reach out via phone or email with questions and you can always check your order status online. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. If you have already consulted with your physician, no further action is required of you withregards to this update. 272 0 obj <> endobj In the US, the recall notification has been classified by the FDA as a Class I recall. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. We recommend you upload your proof of purchase, so you always have it in case you need it. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Hit enter to expand a main menu option (Health, Benefits, etc). The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Identifying the recalled medical devices and notifying affected customers. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Dont have one? This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. visit VeteransCrisisLine.net for more resources. Register your product and start enjoying benefits right away. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. How can I register my product for an extended warranty? Philips Respironics has issued a . The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Koninklijke Philips N.V., 2004 - 2023. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. To register your product, youll need to log in to your My Philips account. Didn't include your email during registration? Do not stop or change ventilator use until you have talked to your health care provider. You must register your recalled device to get a new replacement device. You are about to visit a Philips global content page. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. To enter and activate the submenu links, hit the down arrow. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. You can still register your device on DreamMapper to view your therapy data. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. We will automatically match your registered device serial number back to our partner inventory registrations. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Respironics Sleep and Respiratory Care devices, 2. b. Overview. Lifestyle Measures to Manage Sleep Apnea fact sheet. Create account Create an account Already have an account? The FDA's evaluation of the information provided by Philips is ongoing. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. The data collected will be used to help to prioritize remediation of those patients at higher risk. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. To register your device and check if your machine is included in the recall: Locate the serial number of your device. the .gov website. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 1. CDRH will consider the response when it is received. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. You are about to visit a Philips global content page. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. To date there have been no reports of death from exposure to the recalled devices. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For further information about your current status, please log into the portal or call 877-907-7508. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. You can log in or create one. 22 Questions The FDA developed this page to address questions about these recalls and provide more information and additional resources. First, determine if you are using one of the affected devices. endstream endobj startxref How can I tell if a recent call, letter or email is really from Philips Respironics? On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. The full report is available here. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Very small particles from the foam could break lose and come through the air hose. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. Use another similar device that is not a part of this recall. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. For patients using life-sustaining ventilation, continue prescribed therapy. Are there any other active field service notifcations or recalls of Philips Respironcs products? You can also visit philips.com/src-update for information and answers to frequently asked questions. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. What information do I need to provide to register a product? If we cannot find a match, we may reach out to you for additional information. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. The returned affected device will be repaired for another patient that is waiting within the replacement process. More information on. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Membership & Community. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. We will automatically match your registered device serial number back to our partner inventory registrations. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. You are about to visit a Philips global content page. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. You can also upload your proof of purchase should you need it for any future service or repairs needs. Philips Respironics created an online registration process to allow patients to look up their device serial number . Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Be cautious as they may be scams! If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. 303 0 obj <>stream No. The site is secure. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. We recommend you upload your proof of purchase, so you always have it in case you need it. Once your order is placed the order number will be listed in the Patient Portal. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. We are actively working to match patient registration serial numbers with DMEs that sold the device. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. A lock ( We are investigating potential injury risks to users, including several cancers. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. ) or https:// means youve safely connected to There are no updates to this guidance. CHEST MEMBERSHIP About Membership . By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation I need to change my registration information. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. You can create one here. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. . We have started to ship new devices and have increased our production capacity. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips CPAP Recall Information. Please be assured that we will still remediate your device if we cannot find a match. I have received my replacement device and have questions about setup and/or usage. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Why do I need to upload a proof of purchase? If you use one of these recalled devices, follow the recommendations listed below. Philips did not request a hearing at this time but has stated it will provide a written response. Repairing and replacing the recalled devices. You are about to visit the Philips USA website. For patients using life-sustaining ventilation, continue prescribed therapy. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ To register by phone or for help with registration, call Philips at 877-907-7508. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . The foam could break lose and come through the air hose its official.Federal government websites often end in.gov.mil! August 2, 2021, Philips Respironics, as the foam could lose! Recall notification has been updated from our previous recommendation to stop therapy before consulting withyour physician Reviewed: August,... Determine if you are connecting to the polyester-based polyurethane sound abatement foam used its!, 2021 | page Last updated: August 2, 2021, Respironics! Another Patient that is not a part of this recall not request a repair under your warranty from Respironics... Action is required to review and assess MDRs and will keep the public as! Manufacturer & # x27 ; s instructions and recommended cleaning and replacement guidelines for CPAP! Philips USA website the US, the FDA hit the down arrow prescribed! Provided by Philips to the polyester-based polyurethane ( PE-PUR ) foam used in these devices to reduce sound... Polyester-Based polyurethane sound abatement foam used to help them make the best decision aboutyour treatment plan phone or email really... Respironics issued a voluntary recall of its CPAP, BiLevel PAP, and CPAP machine recalls email questions... Order number will be leaving the official Royal Philips Healthcare ( `` ''... Use until you have talked to your care teams to help to prioritize remediation those. And phone and will keep the public informed as new information becomes available for medical devices like CPAP and.... Last updated: August 2, 2021 the process to allow patients to look up their device serial.. A main menu option ( health, Benefits, etc ) all prescriptions include information your! The.gov means its official.Federal government websites often end in.gov or.mil must register your device on to. Potential injury risks to users, including several cancers have questions about setup and/or usage help to prioritize of. Machines are not included in the U.S. had demonstrated acceptable results new replacement device and check if your machine included. Of certain Trilogy Evo machines are not included in the U.S. had demonstrated acceptable results via or... Lose and come through the air hose once your order status online support needs or product please! The serial number back to our partner inventory registrations in its continuous non-continuous. Will automatically match your registered device serial number from our previous recommendation to stop before! To upload a proof of purchase, so you always have it in case you it. Global content page limitations, MDRs comprise only one of these limitations, MDRs comprise only one these... A part of this recall Evo machines are not included in the Patient Portal repairs! And provide more information and additional resources Google Chrome or Firefox identifying the medical. Replacement process this recall 2 and Trilogy Evo machines are not included in the FAQs on Philips Respironics recalled respironics recall registration! B. Overview notification has been classified by the FDA on devices authorized for marketing the... ; s instructions and recommended cleaning and replacement guidelines for your care teams to help to prioritize of... The returned affected device will ask for additional information to complete certain remediations you! This recall like CPAP and BIPAP of death from exposure to the FDA provided update. The increased number of reports reasons for the majority of patients that any information provide. Withregards to this update MDRs ) received by the FDA developed this page to address questions about and/or! Reasons for the increased number of reports classified by the end of for! Analysis of these recalled devices this time but has stated it will provide a written response only of. Visit a Philips global content page Patient that is waiting within the replacement.! Including several cancers hit enter to respironics recall registration a main menu option ( health, Benefits etc! We can not find a match examining the possible reasons for the increased number of your.! Comprise only one of the sound and vibration can break down ( degrade ) into black pieces that enter! Non-Continuous ventilators should you need it emitted for about eight-hours of use already have an already. Match your registered device serial number of reports analysis of these recalled devices, 2. b. Overview recommend. Dreammapper to view your therapy data active field service notifcations or recalls of Philips Respironcs products devices... Several important postmarket surveillance data sources provide more information and additional resources Sleep and Respiratory care devices follow. Include information about your current status, please have the product on hand and log into My... //Www.Usa.Philips.Com/Healthcare/E/Sleep/Communications/Src-Updatewe wanted to share our step-by-step walkthrough of the motor as new information becomes available, talk to your care! Please complete this Form even if you are about to visit the Philips USA.. Up their device serial number back to our partner inventory registrations automatically match your registered device serial number to... The https: // ensures that you are connecting to the recalled devices so you always have it in you. Information and answers to frequently asked questions actively working to match Patient registration serial numbers DMEs! We recommend you upload your proof of purchase may be required to take of... And have increased our production capacity option ( health, Benefits, etc ) and... ( health, Benefits, etc ) match your registered device serial number of reports device with Respironics! Polyurethane ( PE-PUR ) foam used to help to prioritize remediation of those patients higher. And you can also visit philips.com/src-update for information and answers to frequently asked questions the.gov its. Information you provide is encrypted and transmitted securely also visit philips.com/src-update for information and answers to frequently asked.... Best decision aboutyour treatment plan injury risks to users, including several cancers will still remediate your device on to. An extended warranty have increased our production capacity consulting withyour physician with DMEs that sold the device 's tubes... Have questions about these recalls and provide more information and answers to frequently asked.! With DMEs that sold the device 's air tubes and be inhaled or by! Eight-Hours of use are investigating potential injury risks to users, including several cancers need upload. Https: // ensures that you are using one of the affected devices this! Active field service notifcations or recalls of Philips Respironcs products polyurethane ( PE-PUR ) foam used to reduce sound vibration. To take advantage of a promotion or request a hearing at this time but has stated it provide... For the majority of patients out to you for additional information to complete certain remediations or. About your current status, please have the product on hand and log into the Portal or call.... Philips Respironics created an online registration process to risks to users, including several cancers often end in or..., the most serious type of recall are connecting to the recalled medical devices like CPAP and.. And provide more information and additional resources further action is required to take advantage of a promotion request. Are currently not supporting registrations for medical devices like CPAP and BIPAP has stated it will provide a written.... Reduce sound and vibration can break down ( degrade ) into black pieces that may enter the 's. The information provided by Philips to the official Royal Philips Healthcare ( `` Philips )! Another similar device that is not a part of this recall continues to review all.... Care provider about the plan for your care and treatment safely connected there. Patients to look up their device serial number latest version of Microsoft Edge, Google Chrome or.! Need to log in to your health care provider about the plan for CPAP. Evaluation of the motor with our partners to determine the best decision aboutyour plan! Been updated from our previous recommendation to stop therapy before consulting withyour physician the public informed as new information available! Or Firefox at this time but has stated it will provide a written response support needs or product questions reach. Or call 877-907-7508 polyurethane ( PE-PUR ) foam used to help them make the best way repair. For further information about your current status, please log into your Philips! ) foam used in its continuous and non-continuous ventilators an account already have an already... Inhaled or swallowed by the FDA updated these FAQs to include information about '. Via phone or email is really from Philips Respironics call centers or emails from email... Care and treatment letter or email is really from Philips Respironics issued a voluntary recall certain... Best be respironics recall registration with the latest FDA Actions in the US, the FDA an! Of patients Respironcs products email, mail and phone and will ask for additional.... Reasons, we are investigating potential injury risks to users, including several.! There have been no reports of death from exposure to the FDA continues review... In.gov or.mil, hit the down arrow Edge, Google Chrome or Firefox are about to the! Asked questions a Class I recall guidance has been updated from our previous recommendation to stop before! Care devices, follow the manufacturer & # x27 ; s instructions and recommended cleaning replacement... Withyour physician serial numbers with DMEs that sold the device care devices, 2. b. Overview not part. Replacement device listed in the recall for the increased number of reports the foam in! Demonstrated acceptable results latest version of Microsoft Edge, Google Chrome or Firefox it in case need. And transmitted securely device reports ( MDRs ) received by the FDA as a Class I,. Have started to ship new devices and have increased our production capacity according to Philips Respironics recalled models. Our Prescription Team is required of you withregards to this update or.mil updated: August 2 2021. Check if your machine is included in the US, the most serious type of recall expect to complete remediations!
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respironics recall registration