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FDAJune 14, 2021device

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

What to do

FDA enforcement status: Ongoing

Brands named

philips respironicsphilips

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use — Recall Details · AllClear