A voluntary recall has been issued for Philips Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. The polyurethane foam is used to reduce sound and vibration in these affected devices.
Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. For details from the U.S. FDA click here,
Affected Philips Respironics breathing devices:
| CPAP and BiPAP Devices | |||
| Device Type | Model Name and Number (All 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 | |||
| C-Series S/T and AVAPS | |||
| OmniLab Advanced+ | |||
| Noncontinuous Ventilator | SystemOne (Q-Series) | ||
| DreamStation | |||
| DreamStation Go | |||
| Dorma 400 | |||
| Dorma 500 | |||
| REMstar SE Auto | |||
| Ventilators | |||
| Device Type | Model Name and Number (All Serial Numbers) | ||
| Continuous Ventilator | Trilogy 100 | ||
| Trilogy 200 | |||
| Garbin Plus, Aeris, LifeVent | |||
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | A-Series BiPAP Hybrid A30 (not marketed in US) | ||
| A-Series BiPAP V30 Auto | |||
| Continuous Ventilator, Non-life Supporting | A-Series BiPAP A40 | ||
| A-Series BiPAP A30 | |||
The polyester-based polyurethane (PE-PUR) sound abatement foam in the affected Philips Respironics CPAP, BiPAP, and ventilator devices may:
- Disintegrate into particles which may enter the device’s air pathway and be inhaled or swallowed by the user
- Release certain chemicals into the device’s air pathway, which may be inhaled
The inhalation of particles and chemicals from the foam is extremely dangerous. The foam break down can result in toxic and/or carcinogenic effects resulting in serious injury which can be life threatening, cause permanent impairment or require medical intervention to prevent permanent damage.
The potential risks of the particulate and chemical exposure include:
- irritation to the skin, eye, and respiratory tract
- inflammatory response
- headache
- asthma
- nausea/vomiting
- toxic or carcinogenic effects to organs, such as kidneys and liver
If you have become injured or sick after using one of these unsafe medical breathing devices, please contact the experienced lawyers at Clark, Perdue & List.