Philips recall: FDA proposes new order
By HME News Staff
Updated 10:01 AM CDT, Wed May 4, 2022
WASHINGTON – The Food and Drug Administration’s Center for Devices and Radiologic Health has proposed that an order should be issued to require Philips to submit a plan to repair, replace or refund the purchase price of recalled devices manufactured after November 2015.
The FDA says Philips has the right to an informal hearing prior to the agency’s decision on whether to issue the order.
The CDRH’s proposal is in addition to the FDA’s previous action, under section 518(a), to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices.
Philips last week recorded EUR 165 million in additional provisions in the first quarter of 2022 related to its recall of certain CPAP devices.
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