Philips issues voluntary recall for several sleep apnea treatment machines
HARRISONBURG, Va. (WHSV) - Earlier this year, Philips issued a voluntary recall for several of their CPAP and BiLevel PAP devices.
“The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example, caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions,” the company’s website states.
“The concern is twofold. First, as the machine is used the foam can slowly degrade and the concern would be that it could get either into the lungs or that it can be swallowed,” Heather Miller, ANP-C, with the Sentara Sleep Medicine Specialists explained. “The second is that potentially it can emit noxious fumes that could then be inhaled.”
The recall notice lists a number of devices that they recommend continued use for as they are life-sustaining ventilation. They do however recommend a consultation with your physician to determine how to move forward.
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator (Not marketed in the US)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto Ventilator
- A-Series BiPAP A40
- A-Series BiPAP A30
The recall recommends stopping the use of the following devices but urges users to, “consult with physicians to determine the benefits of continuing therapy and potential risks.”
- DreamStation ASV
- SystemOne ASV4
- OmniLab Advanced Plus
- DreamStation ST, AVAPS
- C Series S/T, AVAPS
- System One 50 series
- DreamStation CPAP, Auto
- Dorma 400, 500 CPAP, Auto CPAP
- System One 60 series
- DreamStation GO CPAP, APAP, Auto CPAP
Miller says those with affected devices should register their machines on the Philips website.
“They have said they will either repair the device or will provide a replacement device. My biggest piece of advice for our patients is to make an appointment with your provider at your sleep clinic and go in a discuss the pros and cons of continued use,” Miller added.
Miller also says that if your machine is more than five years old you may qualify for a replacement without having to wait for the recall.
“Which is one of the other benefits of seeing a provider so they can write orders for that machine,” Miller said.
“The company will replace the current sound abatement foam with new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. Philips aims to address all affected devices in the scope of this correction as expeditiously as possible,” the company’s website states.
To register your Philips device, click here.
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