Philips Respironics Product Recall: Important Information for AvantSleep Clients
July 7, 2021 (latest update)
On June 14, 2021 Philips Respironics announced 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. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.
Health Canada issued a medical device recall June 23, 2021: Health Canada Recall.
Health Canada has categorized this as a Hazard Type II. Type II hazard is defined by Health Canada as a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote. Please see this link for details: Health Canada Hazard Classification.
The device I use is on the list of impacted products. What action do I need to take?
As per Philips Respironics recall notification (U.S. and Canada) / field safety notice (International Markets) the following actions should be taken:
- For patients using BiLevel PAP and CPAP devices: Discontinue use of your device and consult with your physician to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in this recall.
- For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.
For further advice from Philips Respironics, click here to read their press release.
What action is AvantSleep taking?
Patient safety is of utmost importance to us at AvantSleep and we are doing everything we can to address this issue. For existing patients who purchased an impacted Philips Respironics product from AvantSleep, we have already registered your device for corrective action and will communicate with you as we receive more information from Philips Respironics.
For additional information, please read the following recommendations from the American Thoracic Society: Recommendations for Sleep and Critical Care Medicine Professionals Re: Philips Recall Notice. You may wish to bring this letter with you to your physician to help determine whether the benefits of continuing therapy outweighs the risks.
Consider contacting your insurance provider to determine if you are eligible for a new device. Typically, insurance will cover a new device after 5 years of use, but you may be eligible sooner.
Please continue to check our website for the most up to date information regarding the product recall.