The devices are designated as medically necessary for a limited patient population older than 7 years and weighing 40 to 66 lbs who have obstructive sleep apnea and respiratory impairment.
A look at answers to some of the most critical questions about the ongoing recall of millions of CPAP machines, ventilators, and other breathing devices.
This recall is for certain reworked DreamStations that were also recalled in June 2021.
Philips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
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Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price.
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Management responsibility and oversight have been strengthened with organizational changes implemented in Philips Respironics.
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A first-come, first-served replacement strategy may not address patient health risks, so the FDA has recommended a prioritization approach.
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Philips Respironics aims to complete the repair and replacement program for its CPAP recall in the fourth quarter of 2022.
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