Philips is facing another string of recalls in its portfolio, which have received a Class I rating, the most serious type of recall.
There seems to be no limit to Philips’ ventilator safety woes. Nearly a full year after initiating a recall of many of its respiratory devices that has since stretched to encompass around 5.2 million machines distributed around the world, the company continues to accumulate safety notices for those and other devices in its vast Respironics portfolio.
The latest safety event concerns the V60, V60 Plus and V680 ventilators. Though all three models escaped the original far-reaching recall, about 1,500 of the V60 and V60 Plus machines were the target of yet another FDA notice earlier this year.
This time around, the trio of ventilators are the subject of a total recall, spanning at least 99,000 devices distributed across the U.S. and around the world. As of this week, the FDA has issued its most serious Class I rating to the safety notices for all three models.
Read the full article at Fierce Biotech.