Philips Respironics E30 ventilator foam degradation poses inhalation hazard
Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.
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 medical device recall requiring minimum severity of 4 per rubric. Polyurethane foam degradation poses risk of particle inhalation and ingestion, plus chemical off-gassing, in a critical life-support ventilator.
Plain-English summary
Philips Respironics, Inc. is recalling the E30 ventilator with humidifier due to a defect in the polyester-based polyurethane (PE-PUR) foam used in the device. The foam may degrade over time and break down into particles that can enter the device's air pathway. These particles may be inhaled or ingested by patients, and the foam may also off-gas certain chemicals.
The E30 ventilator is used to provide invasive and non-invasive ventilatory support for patients with respiratory insufficiency, including adult and pediatric patients older than 7 years and weighing more than 18 kg. The recall affects all serial numbers of the product models DSX9999H11, INX9999H19, and RINX9999H19. In total, 15,357,775 units have been distributed globally: 10,307,186 in the United States and 5,039,748 internationally.
Healthcare facilities and patients currently using this ventilator should contact Philips Respironics for further instructions on repair, replacement, or return. Due to the critical nature of this device, consult with your healthcare provider before discontinuing use.
The recalled product
- Product
- Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for…
- Manufacturer
- Philips Respironics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19
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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