Philips Respironics recalls BiPAP A40 System Silver JP models with potential VOC exposure and ventilator failure risks. Affected units may cause breathing issues if not addressed.
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 JP ventilators due to plastic parts that could release harmful chemicals and cause sudden device failure. This poses a risk of breathing problems if the ventilator stops working.
The ventilator's motor assembly may contain plastic parts that release harmful chemicals (VOCs) during use. If the device suddenly stops working, it could lead to breathing difficulties if not quickly noticed and fixed by a healthcare provider.
Patients using the BiPAP A40 System Silver JP ventilators for continuous breathing support are most at risk. Healthcare providers who use these devices for non-life-supporting ventilation may also be affected.
Check for the model name 'BiPAP A40 System Silver JP' and serial numbers V305622168DB9, V30562335D64E, V305626872849, or V30562903EA6A. These units were sold with material number 1111177.
Verify if the ventilator is functioning properly and has no unusual smells or sounds.
Reach out to Philips Respironics for guidance on next steps if the device is affected.
The recall indicates a potential risk of harmful chemical release and sudden device failure, but the device is non-life-supporting and requires medical supervision.
Check for the model name 'BiPAP A40 System Silver JP' and serial numbers V305622168DB9, V30562335D64E, V305626872849, or V30562903EA6A.
If the ventilator stops working, contact your healthcare provider immediately to address potential breathing issues.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1628-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1628-2021 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.