The devices — Trilogy 100, Trilogy 200, and Garbin Plus ventilators — were recalled because foam could break away from the plastic backing and block the airpath. Patients can also ingest the foam. Both issues can cause serious injury or death, the FDA said Feb. 16.
As of Jan. 4, 82 medical device reporting complaints were filed. There have been no deaths reported.
Philips has temporarily paused reworking the Trilogy 100 and Trilogy 200 ventilators, according to the FDA.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
