Philips Respironics Recall Includes All v60 and V60 Plus Ventilators; FDA Categorizes Recall as Class 1
The U.S. Food and Drug Administration (FDA) announced on June 3, 2022, that Philips Respironics would recall all V60 and V60 Plus ventilators. The FDA identified the Philips Respironics recall as a Class I recall, the most serious type of recall, for the potential to cause serious injuries or death. The products recalled as part … [Read more...] about Philips Respironics Recall Includes All v60 and V60 Plus Ventilators; FDA Categorizes Recall as Class 1
Philips CPAP, BiPAP, and Ventilator Recalls
According to a news story posted on mddionline.com, the U.S. Food and Drug Administration reported that its inspectors have just completed an inspection of a Philips facility in Pennsylvania. The report states that the FDA may not be satisfied with Philip's replacement foam choice for the recalled Philips Respironics ventilators, … [Read more...] about Philips CPAP, BiPAP, and Ventilator Recalls
Philips Degraded Foam Complaints
According to an online news report posted on informa.com, Royal Philips has been struck with several risk management and quality systems observations following a recent FDA facility inspection. The FDA inspection also revealed that Philips failed to open a formal investigation after it received hundreds of thousands of complaints of … [Read more...] about Philips Degraded Foam Complaints
