Philips Respironics recalls several ventilators due to potential PE-PUR foam degrading into particles that could be inhaled or ingested by users. Affected models include SystemOne (Q-Series), DreamStation, and others.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Philips Respironics is recalling several ventilators that use polyester-based polyurethane foam. This foam may degrade into particles that could be inhaled or ingested by users, posing a health risk. The recall affects specific models used for respiratory support in adults and children over 7 years old.
The polyester-based polyurethane foam in the ventilators may break down into small particles that can be inhaled or swallowed by the user. This could lead to health issues if the particles enter the airway or are ingested.
Adults and children over 7 years old who use the recalled ventilators for respiratory support. Those with respiratory conditions are most at risk.
Check for the following model names: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators. The specific serial numbers and material numbers are listed in the recall notice.
Identify your ventilator model by checking the label on the device or the packaging.
Reach out to Philips Respironics for further assistance or to confirm if your device is affected.
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators.
The polyester-based polyurethane foam may degrade into particles that could be inhaled or ingested by users, and may off-gas certain chemicals.
The recall does not require immediate discontinuation of use; however, it is recommended to contact the manufacturer for guidance.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1974-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1974-2021 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.
