Philips Respironics recalls BiPAP A40 System Silver ventilators due to potential VOC exposure from non-conforming plastic. Affected units may fail suddenly, risking asphyxia if not addressed by care providers.
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.
Philips Respironics is recalling BiPAP A40 System Silver ventilators because some units have plastic parts that could release harmful chemicals. If the device suddenly stops working, it might cause asphyxia if not fixed quickly by a healthcare provider.
The ventilator's motor assembly may contain plastic that releases volatile organic compounds (VOCs), which could pose a biosafety or toxicological risk. If the device suddenly stops working, it might cause asphyxia if not immediately addressed by a healthcare provider.
Healthcare providers using the BiPAP A40 System Silver ventilators for non-life-supporting patients are most at risk. Patients using these devices for continuous ventilation could be affected if the device fails.
Check for the material number R1111177 or serial number V30562261B40E on the device. The BiPAP A40 System Silver model is a non-life-supporting continuous ventilator.
Verify if the ventilator has the material number R1111177 or serial number V30562261B40E.
Yes, the ventilator could release harmful chemicals and might stop working suddenly, risking asphyxia if not addressed by a healthcare provider.
Check for the material number R1111177 or serial number V30562261B40E on the device.
If the ventilator suddenly stops working, contact your healthcare provider immediately to address potential asphyxia risks.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1627-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1627-2021 from Philips Respironics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
