Philips Respironics respiratory ventilators recalled for foam degradation
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum score of 4 per the rubric. Although no illnesses or deaths are reported in the source text, the Class I designation reflects the FDA's assessment of potential for serious harm from foam particle degradation in life-sustaining respiratory devices.
Plain-English summary
Philips Respironics is recalling approximately 229,353 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent continuous ventilators. These devices have global distribution including the United States and are used in homes, hospitals, institutions, and portable applications for both invasive and non-invasive ventilation.
The polyester-based polyurethane (PE-PUR) foam used in these ventilators may degrade over time, releasing particles. Foam degradation could compromise device function and potentially expose patients to inhaled particles during ventilation. The manufacturer identified this risk and added foam replacement to the preventive maintenance schedule in 2018.
However, the 2018 preventive maintenance approach has been superseded by a more comprehensive 2021 recall action. The current action involves device removal and rework to fully address the foam degradation hazard in the affected ventilators.
The recalled product
- Product
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not…
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 229,353
Distribution
Distributed nationwide across the United States.
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