On June 30, 2021, the FDA alerted people who use certain Philips Respironics (Philips) ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines because of potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.
From the start of the recall in June 2021, we have mobilized a dedicated response team across the agency to work on the regulatory efforts related to this recall and address questions and concerns raised by patients and health care providers. This team meets regularly with Philips to monitor and track its handling of this recall. The team has a wide range of expertise and is dedicated to developing FDA’s safety communications, monitoring the status of the recall, reviewing test results and other submissions related to the recall, communicating with patients and health care professionals affected by the recall, and mitigating shortages of these important devices.
The FDA is committed to:
- Ensuring Philips takes appropriate steps to correct their devices and provide safe remediated devices to patients.
- Addressing concerns and questions raised by patients and health care providers about device replacement.
- Keeping the public informed as more information becomes available.
The FDA continues to:
- Monitor Philips' actions related to remediation of impacted devices until Philips has met all requirements related to the conduct of this Class I recall and the Medical Device Quality System regulation.
- Carefully evaluate the totality of information available to the FDA in determining appropriate next steps.
On this page:
- Repair and Replacement Programs for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Medical Device Reports Reportedly Associated with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Shortages of Ventilators, BiPAP Machines, and CPAP Machines
- Proposal that an Order for Device Repair, Replacement, or Refund Should be Issued
- Prioritizing Replacement for Recalled Ventilators, BiPAP Machines, and CPAP Machines
- Notification Order to Improve Communication
- FDA Inspection of a Philips’ Manufacturing Facility
- Other Activities Related to the Philips’ Class I Recall Associated with the PE-PUR Foam
- Philips' Class I Recalls Not Associated with the PE-PUR Foam
- What Philips is Required to Do
- Report a Problem to the FDA
- Questions about Philips’ Recalled Devices?
Related FDA pages
- Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Recommendations for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
Philips has not yet provided the FDA with all the information needed for the agency to evaluate the plan to repair and replace products across all the Philips’ recalled devices. For more information, see What Philips is Required to Do.
- On April 13, 2023, the FDA issued an update to provide transparency for consumers who are awaiting a replacement device. The FDA clarified that the number of replacement and remediated devices that were shipped to consumers in the U.S. was considerably less than the 2,460,000 number of "new replacement devices and repair kits" posted on Philips' website (information displayed until April 14, 2023). The 2,460,000 number included manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers. The FDA was concerned this might impact the estimated wait time for consumers still awaiting a replacement device.
- On April 7, 2023, the FDA issued a recall summary for certain reworked DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all.
- On December 22, 2022, the FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two more potential issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators, as listed below.
- On November 17, 2022, the FDA provided an update that Philips informed the FDA that the Philips Trilogy 100 and Trilogy 200 ventilators reworked as a part of the June 2021 recall have two more potential issues.
- The new silicone sound abatement foam, installed in the reworked ventilators to replace the PE-PUR foam, may potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure.
- Trace amounts of particulate matter have been found in the air pathway of some reworked ventilators.
- In August 2021, the FDA concurred with Philips’ plan for recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto (All Configurations), Dream Station BiPAP; Pro, Auto (All Configurations) and DreamStation ST, ASV, AVAPS (All Configurations), as Philips announced on September 1, 2021. The firm’s announcement also stated: “Philips intends to complete the repair and replacement programs within approximately 12 months.”
Medical Device Reports Reportedly Associated with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
The FDA continues to announce updates about the number of medical device reports (MDRs), including reports of death, which are reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available.
- On October 19, 2023, the FDA updated the device shortage list to remove certain ventilation-related product codes (CBK and NOU).
- On July 14, 2023, after working with other manufacturers and government partners to help make more BiPAP and CPAP machines available, the FDA updated the device shortage list to remove certain ventilation-related product codes (BZD, MNS, and MNT).
- On September 10, 2021, the FDA added certain ventilation-related product codes (MNS and MNT) to the device shortage list due to device availability issues. These product codes, which also include other types of ventilation-related products, are related to CPAP and BiPAP machines.
On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips in which CDRH proposed that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, 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 notice provided Philips an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). Philips did not request a hearing but submitted a written response.
On March 14, 2022, the FDA updated the frequently asked questions to include information about Philips' prioritization strategy for replacement devices. After discussions with health care providers, experts in sleep medicine, and patient groups, the FDA shared with Philips the concerns of health care professionals and people who use these recalled devices, that for some patients, stopping use of the recalled device without an adequate alternative may involve significant risks to individual and public health. A first-come, first-served replacement strategy may not address these risks, or the risks from continued use of the recalled devices that such patients may face. For people with a recalled device, Philips’ online patient portal allows patients to provide additional information to be considered for prioritized replacement and to check the status of replacement devices.
On March 10, 2022, the FDA issued a notification order to Philips requiring the company to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers about the recall and the health risks posed by the foam used in the recalled products. The FDA determined the order was necessary to eliminate the unreasonable risk of harm posed by the recalled devices because the company's notification efforts at that time had been inadequate. The order also directs Philips to maintain prominently displayed information regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall and to provide instructions for device users to register their devices on the Philips website.
Along with these actions, the FDA recommended additional measures to better communicate with the public regarding the recall, including:
- That Philips provide monthly updates to patients and consumers who register their devices on the Philips website that include information on expected time for a replacement device and current rate of replacement of recalled devices.
- That Philips provide detailed information for device users, DME suppliers, distributors, retailers, and healthcare providers on the replacement process.
Issuing the order enabled the FDA to mandate that Philips improve its communication about the recall and the serious risk posed by the PE-PUR foam used in the recalled devices with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.
For more information, please see the section "What Philips is Required to Do" below.
Between August and November 2021, the FDA conducted an inspection of a Philips' manufacturing facility in Murrysville, PA, to determine what may have caused or contributed to the foam issues and assess adherence to the agency’s requirements for quality manufacturing. FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality.
During the inspection, the FDA investigator made several observations that are outlined in an inspection closeout report, also known as an “FDA Form 483.” The FDA investigator provided a list of their observations to the company. An FDA investigator’s list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations.
Following initiation of the recall in June 2021, Philips developed a plan to repair the PE-PUR foam in the recalled CPAP and BiPAP devices with a different, silicone-based foam. The FDA initially approved this plan based, in part, on testing the company provided to the FDA in June 2021 on the new foam.
However, during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, 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). Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA 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.
The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps.
- On January 26, 2022, the FDA provided an update related to the recall of certain Philips ventilators distributed between April 15, 2021 and May 24, 2021, with specific serial numbers. The FDA classified the recall of certain Trilogy EVO ventilators for potential health risks from PE-PUR foam as a Class I recall, the most serious type of recall. These devices were not included in the June 2021 recall of certain Philips ventilators, BiPAP machines, and CPAP machines. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified PE-PUR, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021.
- On July 29, 2021, the FDA posted frequently asked questions (FAQs) about the Philips’ recall of certain ventilators, BiPAP machines, and CPAP machines. The FDA 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 included this feedback in the FAQs.
- In July 2021, the FDA identified certain Philips ventilators, BiPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page.
- On June 30, 2021, the FDA alerted people who use certain Philips ventilators, BiPAP machines, and CPAP machines that Philips voluntarily recalled certain devices due to potential health risks. The PE-PUR foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.
- A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
- A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators
- Continuous Ventilator, Non-life Supporting: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+
- E30 with Humidifier Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- Noncontinuous Ventilators SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto
- In April 2021, the FDA received notification from Philips about their intention to conduct a field action due to concerns pertaining to PE-PUR foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021.
- On October 20, 2023, the FDA issued a recall summary for V60 and V60 Plus Ventilators. Philips recalled the devices due to Power Management Printed Circuit Board Assemblies not meeting ventilator standards.
- On August 14, 2023, the FDA issued a recall summary for Philips Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators. Philips recalled the devices after detecting dust and dirt from the environment in the device air path.
- On September 6, 2022, the FDA issued a safety communication and letter to health care providers to alert patients, caregivers, and health care providers that Philips recalled certain masks used with BiPAP machines and CPAP machines due to a serious safety concern. The recalled masks have magnets and can cause potential injuries or death when use of the mask with magnets interferes with certain implanted metallic medical devices or metallic objects in the body.
- On August 29, 2022, the FDA issued a safety communication to alert patients, caregivers, and health care providers that Philips recalled BiPAP machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern, and it may also cause the machine to fail.
- On June 3, 2022, the FDA issued a recall summary for all Philips V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. The power fluctuation causes a reboot of the backup alarm controller, which may lead to a complete shutdown of the ventilator without warning.
- On March 21, 2022, the FDA issued a recall summary for certain Philips V60 and V60 Plus ventilators because a subset of these devices had parts that were assembled using an expired adhesive. If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.
- On August 3, 2021, the FDA issued a recall summary for Philips V60 and V60 Plus ventilators that provide High Flow Therapy (Software Version 3.00 and Software Version 3.10) due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit. This can occur if the oxygen flow is partially blocked for any reason. If the issue causing maximum system pressure is not resolved by the health care provider, the ventilator will continue to provide the patient with lower oxygen flow rate and issue a low priority alarm.
The FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, requiring Philips to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows:
- As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy which has included:
- Consideration of the results of the health hazard evaluation.
- Request each consignee to provide Philips with contact information for each patient, consumer, or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device.
- In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer, or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device.
- Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page.
- 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. The information available on Philips' website at the time the FDA issued the order was vague and did 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.
- Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device.
Philips' Recall Strategy
In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including FDA's quality system regulations (21 CFR Part 820).
As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy. Philips’ recall strategy has included:
- Consideration of the results of the health hazard evaluation.
- Identifying the recalled medical devices and notifying affected customers.
- Determining the effect or impact of device issues to customers and users.
- Creating a plan to repair or replace recalled devices remaining in the marketplace or field.
- Repairing or replacing the recalled devices.
In addition, the FDA is evaluating the plan to repair or replace the following recalled Philips devices:
- A-series BiPAP machines
- DreamStation Go
- OmniLab Advanced+
- REMstar SE Auto
If you have any problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
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.
For more information on Philips’ recall notification, contact your local Philips representative or visit Philips' medical device recall information page.
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.
If you have additional questions, contact the FDA’s Division of Industry and Consumer Education (DICE).