FDA, Philips parse device numbers
By HME News Staff
Updated 11:34 AM CDT, Mon April 17, 2023
WASHINGTON – The U.S. Food & Drug Administration is seeking to clarify the number of replacement and remediated devices that Philips has shipped to customers in the US.
The April 13 notice states that the FDA is clarifying that the number is considerably less than the 2,460,000 “new replacement devices and repair kits” that Philips states on its 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,” states the FDA.
The FDA is concerned this may impact the estimated wait time for consumers still waiting for a replacement device.
In an email to HME News, Philips said:
“We are looking into how to best address the concern of the FDA. To date, we have consistently reported on the total amount of new replacement devices and repair kits that have been produced and shipped to the country of destination. This means that not all of these devices are already in the hands of patients. To date, approximately 2.2 million devices have been remediated in the US.”
Earlier this month, the FDA announced that Philips had recalled 1,088 certain reworked DreamStation devices distributed between Dec. 1, 2021, and Oct. 31, 2022. For that recall, the company sent affected provider customers and patients an “Important Product Notice” with recommendations. For providers, it says a replacement product will be provided for exchange of affected devices.
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