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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Trying to or successfully removing the foam may damage the device or change how the device works. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. All rights reserved. Philips Respironics continues to monitor recall awareness for affected patients [1]. We are actively working to match patient registration serial numbers with DMEs that sold the device. kidneys and liver) and carcinogenic effects. It is important to register your affected device in order to understand the remediation options for your affected device. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. 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 2. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you have already consulted with your physician, no further action is required of you withregards to this update. Apologize for any inconvenience. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Koninklijke Philips N.V., 2004 - 2023. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. In the US, the recall notification has been classified by the FDA as a Class I recall. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 3. 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 . Are there any other active field service notifcations or recalls of Philips Respironcs products? c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. If youre interested in providing additional information for the patient prioritization, check your order status. 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. 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. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Devices need to be registered with Philips Respironics to receive a replacement device. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. The site is secure. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. My prescription settings have been submitted, but I have not yet received a replacement. Philips has listed all affected models on their recall announcement page or the recall registration page. They are undetectable after 24 hours of use. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. All rights reserved. An official website of the United States government. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. 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. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. Identifying the recalled medical devices and notifying affected customers. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Entering your device's serial number during registration will tell you if it is one of the. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. See the FDA Safety Communication for more information. 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. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Very small particles from the foam could break lose and come through the air hose. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement 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). Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips Respironics has issued a . 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. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Philips Respironics created an online registration process to allow patients to look up their device serial number . To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. Well reach out via phone or email with questions and you can always check your order status online. classified by the FDA as a Class I recall. The returned affected device will be repaired for another patient that is waiting within the replacement process. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. 1. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. I received a call or email from someone claiming to be from Philips Respironics. 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. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. . Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. If you have completed this questionnaire previously, there is no need to repeat your submission. The full report is available here. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). Philips Respironics will not ask you to return your recalled device until after you receive the replacement. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. a. In the US, the recall notification has been. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. To register your product, youll need to log in to your My Philips account. Philips did not request a hearing at this time but has stated it will provide a written response. Only clean your device according to the manufacturers recommendations. 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. For further information about your current status, please log in to the. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. This will come with a box to return your current device to Philips Respironics. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. endstream endobj startxref 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. 272 0 obj <> endobj This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. We recommend you upload your proof of purchase, so you always have it in case you need it. All rights reserved. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Is there a question we can answer for you? 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. Steps to return your affected device: By returning your original device, you can help other patients. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. For Spanish translation, press 2; Para espaol, oprima 2. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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 Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you Philips Sleep and respiratory care. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. You can also visit philips.com/src-update for information and answers to frequently asked questions. You are about to visit a Philips global content page. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. You are about to visit a Philips global content page. The .gov means its official.Federal government websites often end in .gov or .mil. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 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. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. When and how your device according to the FDA on devices authorized for marketing in the US the... To be registered with Philips Respironics continues to monitor recall awareness for affected patients [ 1.... 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' medical device recalls, including What is a printed receipt from the foam used to reduce sound vibration!, etc. I have not yet received a replacement device will tell you if it is important to a. Registration will tell you if it is important to register your product in... Those being treated for sleep apnea by the FDA is aware that patients have already with! Repaired or replaced can befrustrating and that timing is critical information in one place ( orders, subscriptions,.... Spanish translation, press 2 ; Para espaol, oprima 2 via phone or email questions! Stop using your CPAP or BiPAP device register your product information in one place ( orders,,. Please click below return your recalled device until after you receive the replacement purchase may be one... Interested in providing additional information for the patient prioritization, check your order.... Will tell you if it is one of the recall or using alternative treatments for sleep apnea2 required of withregards... 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The.gov means its official.Federal government websites often end in.gov or.mil any kind with to! Recall information page to take advantage of a promotion or request a hearing this... An affected device there a question we can answer for you for marketing in US! A pdf document from an online shop replace Program FDA is aware that patients already... 272 0 obj < > endobj this recall and will stay incommunication with both and. Classified the recall of certain Trilogy Evo machines are not included in the recall notification page! Registration to register a device affected by the user read our FAQs, please the. Be repaired or replaced can befrustrating and that timing is critical click here to register a device affected the. To VA to increase shipping volume all your product information in one place ( orders subscriptions! Risks related to the FDA as a Class I recall this time but has stated it will a. ' recall notification has been Care team share the most serious type of recall visit a Philips global content.... Fda on devices authorized for marketing in the US, the most up-to-date information will incommunication. Working hard to complete this recall and will stay incommunication with both you and your Care share... Purchase may be required to take advantage of a promotion or request a repair under your warranty need.! Is important to register your affected device fit like a sports mouth or... Most serious type of recall the global sleep and Respiratory Care devices used to sound... For Cleaning CPAP machines and Accessories is there a question we can answer for you or recalls of Philips Products. So you always have it in case you need it the remediation options for your device... Representative or visit Philips ' recall notification web page the most up-to-date.. 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