Philips Respironics recall on positive airway pressure devices

Philips Respironics recall on positive airway pressure devices

June 25, 2021

We have recently received a notice from Philips Respironics announcing a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone.

As a patient of our Continuous Positive Airway Pressure (CPAP) Clinic identified to have purchased an affected device, we are bringing this recall to your attention.

Recall: All devices manufactured before April 26, 2021

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

At this time, the following steps are recommended to ensure safety:

  • Stop using your device if you experience the following:
    • See black debris/particles in the circuit, humidifier, tubing or mask
    • Experience headache, upper airway irritation, cough, chest pressure, sinus infections, nausea or vomiting
  • Patients who have severe obstructive sleep apnea (OSA), are not experiencing any of the above symptoms or have underlying cardiovascular issues are advised to continue using their device as per the advice of our sleep doctors
  • If your device is greater than five years old, please have your family doctor send a referral to the sleep clinic to make an appointment to purchase a new machine
  • Stop using any approved or unapproved sanitizing machines with your device (e.g. SoClean, Lumin)
  • Contact your insurance company and see if they would cover the full cost of a new device, if less than five years old 

To date, we do not have any specific timelines or information from the manufacturer for the repair and/or exchange of the devices. The manufacturer has provided a website to register your device on their recall website: 

  •  Register your device on the recall website www.philips.com/src-updates
    • The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two issues.
    • The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
    • Call 1-877-907-7508 if you cannot visit the website or do not have internet access.  

Patient safety is one of our top priorities at Markham Stouffville Hospital. We are dedicated to resolving this issue in a timely manner by working closely with Philips Respironics to find a solution. We appreciate your understanding during this difficult time. Please be advised, we will update our patients as we receive more instructions and information.

If you have any questions or concerns, please contact our CPAP Clinic at cpap@msh.on.ca or 905-472-7373 ext. 6734.