Philips Respironics’ recent recall regarding certain bi-level positive airway pressure machines has now been classified as a Class I recall, the most serious type of recall, according to the U.S. FDA.
Philips’ respiratory device-focused Respironics business has been in the hot seat for well over a year now, ever since it identified a potentially fatal safety issue with the sound-muffling foam of around 5.5 million of its CPAP and BiPAP machines and other ventilators.
Even with that massive recall—and its equally massive repair-and-replace program—well underway, the company has continued to uncover even more issues within its Respironics lineup, resulting in a handful of additional recalls this year alone.
The latest of these, which began at the end of August and concerns several models of Philips’ BiPAP machines, is now the fifth this year to receive the FDA’s most serious rating, denoting an increased risk of serious injury or death. The agency handed down the Class I tag on Friday.
Read the full article at Fierce Biotech.
Featured image: The BiPAP A40 Ventilator was included on the FDA’s summary of recommendations for this latest recall.