Philips, amid its recall of more than 5 million sleep apnea devices and ventilators, has sent “considerably less” replacement or repaired devices to consumers than the 2.46 million posted on its website, the Food and Drug Administration said in a notice on Thursday.
Part of the reason for the discrepancy is that the number Philips shared includes manufactured repair kits that the company shipped internally to its repair facilities, the agency said.
“We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device,” the FDA stated, encouraging patients to contact Philips for an update on their replacement device.
Philips started recalling the devices in 2021 due to the risk of foam used to soundproof the products breaking down and being inhaled by patients. Since then, patients have faced long waits for sleep apnea devices.
Philips spokesperson Steve Klink said in an emailed statement that the company is “looking into how to best address the concern of the FDA.”
To date, the company has reported the number of replacement devices and repair kits that have been produced and shipped to the country of destination, which means not all of them are already in the hands of patients, Klink said. About 2.2 million devices have been remediated and sent to patients in the U.S.
Philips said in December that it was on track to finish production for 90% of replacement devices by the end of the year.