 
To provide transparency for consumers who are awaiting a replacement device, the U.S. Food and Drug Administration (FDA) is clarifying that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the 2,460,000 number of "new replacement devices and repair kits" posted on Philips' website. The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers. We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device. We encourage consumers to contact Philips to get an update on the status of their replacement device.
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Questions?
The FDA.gov website includes FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls to address questions about the recalls and provide additional resources with more information.
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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