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 distributed across Canada because the foam used in these machines may break down and release particles that users could inhale. This recall affects multiple models of these breathing assistance devices used by patients with sleep apnea and other respiratory conditions. The FDA classified this as a Class I recall, indicating a serious health risk.

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/ba568664-3909-42a1-a7f1-b6478614aa57