FDA issues serious recall for Philips respiratory devices.
TL;DR Summary
The FDA has issued a Class I recall for certain Philips Respironics DreamStation CPAP machines due to a programming error that could cause serious health problems or death. The machines help people with sleep apnea by keeping their airways open during sleep. Philips has received 43 complaints about the issue, but there have been no reported injuries or deaths. The recall involves 1,088 machines distributed from December 1, 2021, to October 31, 2022. Affected customers are encouraged to contact their healthcare provider for a manual reset of pressure or to wait for a replacement device.
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- Philips re-recalls 1,200 CPAP, BiPAP machines repaired in far-reaching ventilator probe FierceBiotech
- US FDA identifies recall of Philips' respiratory devices as most serious Reuters
- Philips Respironics recalls some reworked DreamStation devices, deemed Class I by FDA Mass Device
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