 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA updated its frequently asked questions about the Philips Respironics CPAP, BiPAP, and ventilator recall on FDA.gov to include information about Philips Respironics’ prioritization strategy for replacement devices.
After discussions with health care providers, experts in sleep medicine, and patient groups, the FDA shared with Philips Respironics 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 Respironics’ online patient portal now allows you to provide additional information to be considered for prioritized replacement and to check the status of your replacement device. You may visit the online patient portal and update your information even if you did not receive an email notification from Philips Respironics.
Questions?
For more information about the status of your replacement device or to update your record with prioritization information, go to the Philips Respironics’ online patient portal or call 1-877-907-7508.
For more information on the recall notification, contact your local Philips representative or visit Philips Respironics’ recall notification page.
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.
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