List of Recalled Philips Products: CPAP Machines, BiPAP Devices, and Ventilators
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On June 30, 2021, the FDA issued a Safety Communication document concerning the June 2021 recall of certain Philips CPAP machines, BiPAP devices, and mechanical ventilators. Therein the FDA provided a list of recalled Philips products and pointed out the potential health risks for patients who used the recalled Philips products.
That June 2021 FDA document, “Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication“, started with this rather alarming paragraph:
The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected 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.
Below, we present Philips “product identification” information from the June 2021 Philips recall FDA Safety Communication that is limited to only those recalled Philips CPAP machines, Philips BiPAP devices, and Philips ventilators that are intended for home use by patients in the US:
- 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
Further, in this document, “Medical Device Recall Notification — Philips Respironics Sleep and Respiratory Care devices“, from Philips Respironics, there is some additional brand-name information for the various Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices that are included in this June 2021 Philips products recall.
We will watch for any additional, new Philips recall “product identification” information that might be forthcoming from Philips, or the FDA as well as other medical device regulatory agencies around the world. To the extent necessary, we will modify the above list of recalled Philips products.
Potential Health Risks for Patients Who Used the Recalled Philips Products
In their June 2021 Safety Communication about the recalled Philips breathing products, the FDA pointed out some of the Philips recall health risks for patients:
The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.
The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects. [Emphasis added]
Since the Philips recall of ventilators, BiPAP, and CPAP machines was issued on June 14, 2021, there has been discussion about the Philips recall health risks for patients from possible toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam part. It has been said that the harmful foam problem in defective Philips devices might cause cancers, lung diseases, organ failures, and other medical conditions in patients who used these recalled Philips products in the past.
Returning to the June 2021 FDA Safety Communication about the recalled Philips breathing products:
The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue.
Of course, we will monitor the medical literature and medical device regulatory realm for more insights about the Philips recall health risks for patients.
When Will the Recalled Philips Products Start to be Repaired or Replaced?
Philips Respironics issued this document, “Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification“, on September 1, 2021.
In relevant part, it states: “Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices” and “intends to complete the repair and replacement programs within approximately 12 months.”
(Last updated: 9/13/2021)