Philips Respironics recall

In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. These devices were recalled because of a breakdown of the foam used to reduce sound and vibration.

What caused the recall?

The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If you’re using the machine, small foam particles may break loose and travel through the air hose. It may even release some chemical vapors.

What harmful effects can it cause?

When the polyester-based polyurethane foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent injury to users.

What effect will heat and humidity have?

The foam damage may get worse in hot and humid settings and by using ozone or ultraviolet (UV) light cleaners or other cleaning methods not recommended by the manufacturer.

If you use a Philips Respironics CPAP (continuous positive air pressure) or BiPAP (bi-level positive airway pressure) machine for sleep apnea, then you should check and see if your device is on the recall list.

Devices that are recalled

The most commonly used CPAP/AutoPAP devices used in the treatment of obstructive sleep apnea from Philips Respironics are called dreamStation CPAP's and DreamStation APAP

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation Go - DreamStation GO CPAP, APAP, Auto CPAP

Other CPAPs recalled

Dorma 400, 500 - Dorma 400, 500 CPAP, Auto CPAP (not marketed in US)

Continuous Ventilator, Non-life Supporting

DreamStation ASV - Also known as DreamStation BiPAP autoSV
DreamStation ST, AVAPS - Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
SystemOne ASV4 - Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced

System One BiPAP and AVAPS

C Series ST, AVAPS - Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
OmniLab Advanced Plus(sleep lab) CPAP
OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator - 50 Series CPAP, ASV
System One 50 series - CPAPs, Auto CPAP, BiPAPs
System One 60 series - CPAPs, Auto CPAP, BiPAPs

Trilogy ventilators

In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators with specific serial numbers, also related to the potential health risks posed by the polyester-based polyurethane foam. The following are the affected devices.

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers
Continuous Ventilator - Trilogy 100
Trilogy 100 Ventilator -
Trilogy 200 - Trilogy 200 Ventilator - Garbin Plus, Aeris, LifeVent Ventilator
Garbin Plus, Aeris, LifeVent Ventilator (not marketed in US)
Continuous Ventilator, Minimum Ventilatory Support, Facility Use

BiPAPs

A-Series BiPAP Hybrid A30 - Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US)
A-Series BiPAP V30 Auto Ventilator - also known as BiPAP V30 Auto Ventilator (A-Series)

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40 - Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US)
A-Series BiPAP A30 - Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US)

For a full list of the recalled devices, see the manufacturer's website.

What steps to take?

If you use a Philips Respironics CPAP or BiPAP device, like a Dream Station or System 1, continue to use your device as prescribed.

How to get them repaired or replaced?

Following the June 2021 recall, Philips Respironics developed a plan to repair or replace recalled devices using a different, silicone-based foam approved by the FDA.

On September 1, 2021, Philips Respironics announced the start of its repair and replacement program for recalled first-generation DreamStation CPAP and BiPAP devices.

Getting a new device:

Register your device on the Philips Respironics website or call 877-907-7508.
You’ll receive a new machine when one is available. It could take up to a year.
They’ll provide a box to return your old device when the new one is received.
Call your sleep doctor to learn what to do next or to learn about alternative options.

External links

FDA page

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