Philips Respironics ventilators recalled for degrading foam and chemical hazards
Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.
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: This is an FDA Class I recall, which carries a minimum severity of 4. Although no specific illnesses or injuries are reported in the source text, the degradation of foam components in life-sustaining ventilators constitutes a serious potential health hazard.
Plain-English summary
Philips Respironics, Inc. is recalling multiple ventilator models due to degradation of polyester-based polyurethane (PE-PUR) foam used in the devices. The foam may degrade into particles that could enter the air pathway and be ingested or inhaled by patients. Additionally, the foam may release certain chemicals through off-gassing.
The affected ventilator models include SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto, and E30. Approximately 15.3 million units have been distributed globally, including over 10.3 million in the United States. These ventilators are intended for patients with respiratory insufficiency, including adults and pediatric patients over 7 years of age.
The FDA classified this as a Class I recall, indicating a serious potential health hazard. Patients currently using affected ventilators should contact their healthcare provider or Philips Respironics for guidance regarding continued use. Patients should not discontinue use without medical advice, as cessation could pose serious health risks.
The recalled product
- Product
- SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It…
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilators
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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