FDA Clarifies Philips BiPAP, CPAP Replacement Numbers

FDA issued a 4/13 updated medical device safety communication to provide transparency for consumers who are awaiting a Philips replacement BiPAP or CPAP machine to clarify 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 “new replacement devices and repair kits” shown on the Philips Web site.

The safety communication says the Philips number includes manufactured repair kits that the company 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,” the notice says. “We encourage consumers to contact Philips to get an update on the status of their replacement device.”

The devices were recalled in 2021 due to potential health risks.