Philips Respironics CPAP/BiPAP Recall
Patients with sleep apnea currently using a Philips Respironics CPAP/BiPAP device:
On June 14, 2021, Philips Respironics voluntarily issued a recall on some
of their CPAP/BiPAP/ASV machines due to concerns for potential health
risks. This has to do with potential degradation of a foam used to dampen
sound in the devices with risk for inhalation and ingestion of foam particles.
The reported potential health risks include headache, irritation, inflammation,
respiratory issues, and possible toxic and carcinogenic effects. The complaint
rate identified by Philips was 0.03% in 2020.
To review a list of the affected CPAP/BiPAP/ASV models, please scroll down
to the bottom of the page.
Philips is working to fix this problem by replacing affected devices. Philips
advises patients to stop using these CPAP/BiPAP devices; if patients continue
using the devices, they should consult with their medical providers and
weigh the risks and benefits.
In some cases, it might be beneficial to consider the continued use of
the current CPAP/BiPAP/ASV devices, particularly when severe sleep apnea
and/or severe symptoms are present. While waiting for a replacement device,
patients should be aware of, and closely monitor for, the potential health
risks reported by Philips.
This recall by Philips is recent and research into the severity and extent
of the risk is still ongoing.
Philips recommends using an inline bacterial filter (you can obtain one
from your DME provider), following manufacturer’s recommendation
for cleaning the device, and discontinuing use of ozone-based PAP cleaning
devices such as the SoClean.
Please contact your DME provider and visit the Philips website (www.philips.com/src-update) for updates and call Respironics Recall Support Hotline (877.907.7508)
to place a claim on your unit. If you would like to discuss this further,
you can call Mary Washington Sleep Medicine at 540.741.7846 to schedule
a visit with your doctor.
Neal Maru, MD and Pascal Ngongmon, MD
Mary Washington Sleep Medicine
All Devices manufactured before 26 April 2021 (DreamStation 2 is not affected)
C-Series S/T and AVAPS
REMstar SE Auto
E30 (Emergency Use Authorization)
Other Information: If you need any further information or support concerning
this issue, please contact the recall support hotline or visit the website:
Philips recall letter