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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. To register your product, youll need to log in to your My Philips account. We may request contact information, date of birth, device prescription or physician information. The DME supplier can check to see if your device has been recalled. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. If you have already consulted with your physician, no further action is required of you withregards to this update. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. 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. 1. Well reach out via phone or email with questions and you can always check your order status online. You can log in or create one here. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating.
No. For patients using life-sustaining ventilation, continue prescribed therapy. 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. There are no updates to this guidance. To register your product, youll need to. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. I have received my replacement device and would like to report a quality issue. I need to change my registration information. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Our Prescription Team is required to review all prescriptions. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines.
You can also visit philips.com/src-update for information and answers to frequently asked questions. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. 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. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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. Official websites use .gov
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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. Hit enter to expand a main menu option (Health, Benefits, etc). Questions regarding registration, updating contact information (including address), or to cancel a registration. Creating a plan to repair or replace recalled devices. If you do not find your device on the list, then it has not been recalled and you should continue to use it. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Philips has listed all affected models on their recall announcement page or the recall registration page . 2. 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. secure websites. Once your order is placed the order number will be listed in the Patient Portal. The full report is available here. hmk9^a,-S{9zk|v-Xh4iv3K&
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You can log in or create one. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Do not stop or change ventilator use until you have talked to your health care provider. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Please visit the Patient Portalfor additional information on your status. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX
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Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). The .gov means its official.Federal government websites often end in .gov or .mil. 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 . CDRH will consider the response when it is received. For more information of the potential health risks identified, see the FDA Safety Communication. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. I am experiencing technical issues with the Patient Portal. If you are in crisis or having thoughts of suicide,
The FDA developed this page to address questions about these recalls and provide more information and additional resources. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. Register your product and start enjoying benefits right away. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Consult with your physician as soon as possible to determineappropriate next steps. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. For further information about your current status, please log into the portal or call 877-907-7508. endstream
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The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. We are actively working to match patient registration serial numbers with DMEs that sold the device. If you use one of these recalled devices, follow the recommendations listed below. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. 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. visit VeteransCrisisLine.net for more resources. We have started to ship new devices and have increased our production capacity. That will allow them place an order for your supplies. More information is available at http://www.philips.com/src-update. The more we know about these devices the more research we can do.". The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. 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. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. 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). Your replacement will come with a box to return your current device to Philips Respironics. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. Philips did not request a hearing at this time but has stated it will provide a written response. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Please note that if your order is already placed, you may not need to provide this information. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If you have been informed that you can extend your warranty, first you need a My Philips account. Cleaning, setup and return instructions can be found here. They are undetectable after 24 hours of use. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. There were no reports of patient injury or death among those 30 MDRs. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Very small particles from the foam could break lose and come through the air hose. No. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? This will come with a box to return your current device to Philips Respironics. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. To access the menus on this page please perform the following steps. Is there a question we can answer for you? You may have to contact your care provider to program the device to your prescribed settings. 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. Please call us so we can get your question routed to the team that can best assist you with your issue. Lock
Use another similar device that is not a part of this recall. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Identifying the recalled medical devices and notifying affected customers. In the US, the recall notification has been classified by the FDA as a Class I recall. CHEST Issues Joint Statement in Response to Philips Device Recall . Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. 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 You are about to visit the Philips USA website. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. Foam: Do not try to remove the foam from your device. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 22 Questions The FDA has reached this determination based on an overall benefit-risk assessment. Follow the recommendations above for the recalled devices used in health care settings. You are about to visit the Philips USA website. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. 2. Didn't include your email during registration? a. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. Secure .gov websites use HTTPS
Apologize for any inconvenience. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls.