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RECALL: Philips Respironics Voluntary Recall of Certain PAP Devices

By Expert Sleep Medicine on June 15, 2021 in Sleep
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Philips CPAP Recall Information

Expert Sleep Medicine was recently made aware of an ongoing voluntary recall of certain Philips Respironics devices:

Message from Philips Respironics:

Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.

The affected devices are not ones that we distribute through our in-house durable medical equipment department. However, the affected devices are common to many DME distributors, according to the Philips website the affected CPAP and BiLevel PAP devices are:

CPAP and BiLevel PAP Devices
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers:

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30 (Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting
DreamStation (ASV)
DreamStation (ST, AVAPS)
SystemOne (ASV4)
C Series (ASV, S/T, AVAPS)
OmniLab Advanced Plus (In-Lab Titration Device)

Non-continuous Ventilator
SystemOne (Q series)
DreamStation (CPAP, Auto CPAP, BiPAP)
DreamStation GO (CPAP, APAP)
Dorma 400, 500 (CPAP)
REMStar SE Auto (CPAP)

Mechanical Ventilators
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator
Trilogy 100 (Ventilator)
Trilogy 200 (Ventilator)
Garbin Plus, Aeris, LifeVent (Ventilator)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30 (not marketed in US)
A-Series BiPAP V30 Auto (Ventilator)

Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40 (not marketed in US)
A-Series BiPAP A30 (not marketed in US)

What if I have an affected device?

We are waiting additional information from Philips Respironics on how current patients utilizing these machines should proceed; you may also hear from your DME company.

Currently, Philips Respironics has determined these steps should be taken immediately by current CPAP and Bi-Level PAP users:

  1. Discontinue use of your device and work with your physician to determine the most appropriate options for continued treatment.
  2. Register your device, using your device Serial Number, by calling 877-907-7508.

UPDATE: The recall registration form is now available: https://www.philipssrcupdate.expertinquiry.com

At this time, the Philips Respironics recall online registration form is not available.  Once available, it will be found at philips.com/src-update. This website will also provide you current information on the status of the recall and how to receive permanent corrective action to address the two (2) identified issues.

We will continue to update you with additional information on this recall as it is made available.