Continuous Positive Airway Pressure (cpap), Bi-level Positive Airway Pressure (bipap), And Mechanical Ventilators (2021-06-14)

Recall Summary Philips is recalling certain CPAP, BiPAP, and mechanical ventilator devices used to treat sleep apnea and respiratory conditions because the foam used in these devices can degrade and release particles that users may inhale. This recall affects devices distributed across Canada. The FDA classified this as a Class I recall, the most serious category.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-06-23

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5700110f-788b-49a9-be6c-d2614493477d