FDA deems Philips Respironics recall of respiratory devices as serious.
The U.S. Food and Drug Administration has issued a new alert about Philips Respironics' continuous positive airway pressure (CPAP) machines, which were recalled in June 2021 due to foam inside the units breaking off and blowing into users' mouths. The repaired machines have also been recalled, as they were given the wrong or a duplicate serial number when Philips re-programmed them. The error can cause the devices to deliver the wrong prescription to sleep apnea patients, or fail to offer any therapeutic benefits, which could lead to respiratory failure or heart failure. Philips has received 43 complaints about the reworked machines, although no injuries or deaths have been reported.
- Philips Respironics is a serious recall, FDA officials say CBS News
- Some Philips CPAP, BiPAP machines may not work as intended, FDA says in recall CNN
- 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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