FDA Class I Recall Means Philips CPAP Machines May Cause Serious Injuries or Death
We are no longer handling these cases.
On July 22, 2021, the FDA issued a Medical Devices Recalls alert about certain Philips CPAP machines as well as Philips BiPAP devices and Philips ventilators. This FDA alert, “Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals“, started with this serious warning:
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. [Emphasis added]
From that same Philips recall FDA alert, in the “Reason for Recall” part, we get these details:
Philips Respironics, Inc., is recalling its Continuous and Non-Continuous Ventilators due to the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, which 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 exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.
There have been more than 1200 complaints and more than 100 injuries reported for this issue. [emphasis added]
This July 2021 Class I recall FDA warning applies to the following Philips CPAP machines, Philips BiPAP devices, and Philips ventilators (current as of 7/27/2021):
- CPAP and BiPAP Devices: Continuous Ventilator, Non-life Supporting
DreamStation ST, AVAPS
C-Series ASV, S/T, AVAPS
- CPAP and BiPAP Devices: Noncontinuous Ventilator
DreamStation CPAP, Auto CPAP, BiPAP
DreamStation Go CPAP, APAP
Dorma 400 CPAP
Dorma 500 CPAP
REMStar SE Auto CPAP
- Ventilators: Continuous Ventilator
Garbin Plus, Aeris, LifeVent
We point out that the list above is limited to only those recalled Philips CPAP machines, Philips BiPAP devices, and Philips ventilators which are intended for home use by patients in the US.