Philips Respironics recalls Brazil-sold BiPAP A30 ventilators with non-conforming plastic that may release harmful VOCs and cause sudden failure. Affected units have specific material and serial numbers.
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 Brazil-sold BiPAP A30 ventilators due to plastic components that could release harmful chemicals and cause sudden device failure. This poses a risk of asphyxiation if the ventilator stops working without immediate detection.
The ventilator's motor assembly contains plastic that may release volatile organic compounds (VOCs), creating a potential health hazard. If the device suddenly stops working, it could lead to asphyxiation if not immediately detected by the healthcare provider.
Patients using the BiPAP A30 ventilator in Brazil are most at risk. Healthcare providers who rely on this device for continuous ventilation may also be affected.
Check for the material number BR1111143 or serial numbers N306151248079 and N306164395E34 on the device. These units were sold in Brazil and are non-life-supporting continuous ventilators.
Verify if your BiPAP A30 has the material number BR1111143 or serial numbers N306151248079 or N306164395E34.
The ventilator's motor assembly contains plastic that may release harmful VOCs and could cause sudden device failure leading to asphyxiation.
Check for the material number BR1111143 or serial numbers N306151248079 or N306164395E34. If you have these, contact Philips Respironics for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1629-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1629-2021 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.
