On June 14, 2021, Philips Respironics/Respironics Inc. released a Medical Device Recall Notification (https://www.philips.ca/healthcare/e/sleep/communications/src-update) announcing a voluntary recall of its Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators due to associated health risks. Health Canada since issued a Recall on June 23, 2021, listing 35 affected products by name. The full list of affect products and Health Canada’s reasons for the Recall can be found at: https://recalls-rappels.canada.ca/en/alert-recall/philips-respironics-recalls-several-models-cpap-and-bilevel-pap-machines-and
According to the manufacturer’s Recall and according to Health Canada, the polyester-based polyurethane foam used for sound abatement in the listed devices may degrade due to high heat and humidity. The degraded foam may turn into particles and it may also emit certain chemicals. Be aware that unapproved cleaning methods may accelerate the foam degradation.
In the recall, the manufacturer warned that there are potential health risks associated with exposure to those particles and chemicals. The manufacturer listed the following as potential safety hazards associated with use: irritation to skin, eyes, and respiratory tract, inflammatory response, headache, asthma, adverse effects on organs, and toxic carcinogenic affects. Further information on the potential health risks can be found at: https://www.philips.ca/healthcare/e/sleep/communications/src-update#questions_and_answers
Aveiro Sleep acknowledges that the recall recommends Consumers take the following actions:
- For patients using life-sustaining mechanical ventilator devices, do not stop or alter your prescribed therapy until you have spoken with your physician.
- For patients using BiLevel PAP and CPAP devices, discontinue use of your device and consult your physician or Durable Medical Equipment provider to determine the most appropriate option for continued treatment.
In light of these recommendations, Aveiro Sleep stresses the importance that Consumers directly consult with their physicians to obtain individual medical advice regarding their use of an affected device. Upon seeking individual medical information from a physician, the patient may then be better able to weigh the risks of continuing use against the risks of discontinuing use.
Aveiro Sleep and Sleep Medix have started to receive replacement devices for recall affected devices < 5 years old. We are unaware of the anticipated timeframe for the repair or replacement of devices > 5 years old and are awaiting further guidance from the manufacturer. Aveiro Sleep and Sleep Medix acknowledges the urgency to provide replacement devices or repairs for all patients; however, Aveiro Sleep and Sleep Medix do not control the supply quantity of the replacement devices from the manufacturer.
Next Steps:
1. Check to see if your device serial number is affected by the recall: https://www.philipssrcupdate.expertinquiry.com/
2. Register your recalled device: https://www.philipssrcupdate.expertinquiry.com/
Alternatively, contact the manufacturer at 1-877-907-7508 to assist with device registration.
3. Please contact your local Sleep Clinic to check for an available replacement device and to further schedule a replacement exchange appointment.
Aveiro Sleep patients, please call 1-855-852-2989 or email [email protected].
Sleep Medix patients, please call 1-780-989-5440 or email [email protected].
Reminder: At this time, ONLY affected recalled devices < 5 years old are eligible for replacement. This would include Dreamstation 1 and Dreamstation Go devices.
Aveiro Sleep understands how important your therapy is to your health and well-being. We appreciate your patience as we navigate through this challenge.
Sincerely,
Sleep and Respiratory Team – Aveiro Sleep and Sleep Medix
