The Recall Desk
SevereFDA (Devices)·Z-1972-2021·Announced 2021-07-21

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 indiv
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory / Ventilator
Hazard
  • foam-degradation
  • inhalation-hazard
  • ingestion-hazard
  • chemical-off-gassing

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.

Related recalls

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