Philips Respironics recalls Brazil-sold BiPAP A40 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 certain BiPAP A40 ventilators sold in Brazil due to plastic material that could release harmful chemicals and cause sudden device failure. This poses a risk of exposure to toxic fumes and potential asphyxiation if the device stops working.
The ventilators contain non-conforming plastic that can 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 and addressed by the healthcare provider.
Patients using the BiPAP A40 ventilator for continuous breathing support in Brazil are most at risk. Healthcare providers who use these devices daily may also be affected.
Check for the material number BR1111169 or serial numbers V306120599B37, V3061207124CF, V30612105753F, or V306121267414 on the device. These units were sold in Brazil.
Verify if your BiPAP A40 has the material number BR1111169 or the listed serial numbers.
The ventilators contain non-conforming plastic that could release harmful VOCs and cause sudden failure, risking exposure to toxic fumes or asphyxiation.
Check the material number and serial numbers on your device. If it matches the recalled units, contact Philips Respironics for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1630-2021 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.
