www.fdanews.com/articles/211774-fda-says-philips-overstated-the-number-of-recall-replacements-shipped-to-consumers

FDA Says Philips Overstated the Number of Recall Replacements Shipped to Consumers

April 17, 2023

The FDA has updated Philips customers that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is far less than the number — 2.46 million — the company announced on its website.

The agency clarified that Philips’s posted number includes repair kits the company shipped internally to their repair facilities, not to consumers.

“We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device,” the agency said.

This news is related to the June 2021 recall of certain ventilators, bilevel positive airway pressure machines, and continuous positive airway pressure machines.

The FDA urges consumers to contact the company to receive an update on the status of their replacement devices.