FDA (Devices) recall action 87753
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips Respironics is recalling 22 BiPAP V30 Auto ventilators because non-conforming plastic in motor assemblies may cause toxic off-gassing or sudden device failure.
Philips Respironics is recalling two BiPAP A30 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.
Philips Respironics is recalling 10 BiPAP A40 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.
Philips Respironics is recalling four BiPAP A40 ventilators because non-conforming plastic in the motor assembly may cause toxic off-gassing or sudden device failure.
Philips Respironics is recalling four BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may off-gas or fail, posing asphyxia risks.
Philips Respironics is recalling specific BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may cause off-gassing or sudden device failure.