The Recall Desk

FDA (Devices) recall action 88058

Philips Respironics, Inc. recalled 3 products on 2021-07-21

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-07-21
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • SevereFDA (Devices)··2021-07-21

    Philips Respironics ventilators recalled due to foam degradation and chemical release

    Philips Respironics ventilators and respiratory support devices are being recalled because polyurethane foam components may degrade into particles that can be inhaled or ingested, and the foam may release harmful chemicals.

    Product
    DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individu
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    0 states
  • SevereFDA (Devices)··2021-07-21

    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.

    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
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    0 states
  • SevereFDA (Devices)··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.

    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
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    0 states