Update on Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
Today, the U.S. Food and Drug Administration (FDA) is providing an update on the recalled Philips Respironics (Philips) ventilators, BiPAP machines, and CPAP machines associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam.
As part of our continued commitment to ensure consumers have the latest information on the Philips recall, the FDA has developed a new resource section on the FDA.gov website. Patients, consumers, and health care providers have played an integral part in providing feedback to the FDA about the Philips’ recall. The FDA has included this feedback in this new resource, and we remain committed to addressing concerns and questions that may arise.
The new web resource includes:
- Information about medical device reports the FDA has received, including updated numbers of reports received through June 30, 2023.
- Summaries of FDA activities related to recalled Philips ventilators, BiPAP machines, and CPAP machines.
- Recommendations for consumers with recalled devices, which have not changed and are consistent with our November 2021 safety communication.
- The latest information on the PE-PUR foam testing.
The FDA will continue to keep the public informed as more information becomes available.
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Questions?
For additional information about the recall, contact your local Philips representative or visit the Philips’ recall notification page.
For more information on FDA medical device recalls, visit What is a Medical Device Recall.
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