Philips Receives FDA Clearance to Repairing Millions of Recalled Sleep Apnea Machines
A news report posted on medtechdive.com states that Philips has received permission from the U.S. Food and Drug Administration to start repairing recalled “first-generation DreamStation devices.” The repair involves replacing toxic sound abatement foam on millions of ventilators and sleep apnea machines.
Philips announced that the company would start repairing the breathing machines this month, according to a company press release. Philips has begun replacing affected DreamStation CPAP devices in the United States with a more modern version of the breathing machine. The replacement and repair program is also being initiated in several other countries. Philips plans to have rolled out the replacement and repair program in most countries by the end of September and expects to complete the replacement and repair programs by September 2022.
CEO Frans van Houten reported to the media that Philips fully recognizes that the timeframe needed to remediate all of the affected breathing machines puts patients in a difficult circumstance. He said the company has significantly increased its production, rework, service capacity, and has intensified its outreach to our customers.
The Philips DreamStation CPAP and ventilator recall was initialized after it was discovered that the sound abatement materials used in the manufacturing of the breathing machines can deteriorate. When the sound abatement material deteriorates, it releases toxic particles and carcinogenic fumes. The recall was announce back in July 2021 and affects millions of Philips ventilators, CPAP, and BPAP machines.
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