PRESS RELEASE JUNE 22, 2021
Procedure to follow, following the recall from Philips
PROCEDURE 1.
Consider the benefits of your treatment before deciding to put an end to it for a risk of 3 problems reported by 10 000 patients. 9,997 out of 10,000 individuals did not report a problem. So far, the majority of our patients feel confident that there are more benefits by continuing the treatment rather than quitting but; the immediate decision is up to you. Until you can discuss it with your doctor.
PROCEDURE 2.
Schedule an appointment with your physician.
PROCEDURE 3.
Consult the document on our website titled “Decision support between the physician and the patient regarding the discontinuation, substitution or continuation of therapy.
PROCEDURE 4.
Register your device on the Philips website to receive the information https://www.philips.ca/healthcare/e/sleep/communications/src-update
Watch our short video on our site for the sign up procedure.
PROCEDURE 5.
Philips will rectify the situation by either changing your device or the affected part of your device/noise sealing foamThese measures. We have yet to know the time limits for correcting this situation but, it is estimated that it will take several months.
PROCEDURE 6.
We will communicate with you via email, Facebook and our website regarding the information provided by Philips Respironics.
New information will be posted as required.
PRESS RELEASE JUNE 17, 2021
High priority: Voluntary recall of Continuous Positive Airway Pressure (CPAP) Philips Respironics devices
Dear customer,
If you have a Philips Respironics device, it is covered by a voluntary manufacturer’s recall notice.
Philips Respironics has issued a voluntary recall of its devices due to possible deterioration and emission of volatile organic compounds from the noise reducing foam. Rare health problems have been cited.
Philips has stated that “The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone, and certain environmental conditions involving high humidity and temperature.”
Philips Respironics recommends discontinuing the use of the devices and recommends users discuss the benefits of continued treatment and the potential risks with their doctor.
Patients using ventilator devices should continue treatment pending discussion with their doctor.
The manufacturer has implemented corrective measures which consist of changing the device or replacing the noise-reducing foam. However, there is no information to date on the timeframe to obtain a replacement.
Our management team has provided your doctor with this information as well as tools to guide you in your decision to continue your treatment. These documents are available on our website
The Côté Santé team is in no way authorized to give you medical advice on whether or not to continue your treatment. Only a doctor can do that.
This type of recall is not only out of our control, but it is also unprecedented in the sleep industry. Philips Respironics is one of the world's largest manufacturers of sleep apnea devices. Therefore, this is a worldwide recall.
Please rest assured that we will keep you informed of developments and any manufacturer solutions as soon as we are able to do so.
Visit https://www.cotesleep.ca/philipsrecall for links to the manufacturer's news releases, documents for your doctor and advice should you decide to temporarily stop treatment (Mesures de mitigation de l’AOS non traitée (Untreated OSA Mitigating Measures), page 14 of the COVID-19 document: https://cotesante.ca/cpap-et-covid-19)
Philips Respironics updates
https://www.philips.ca/healthcare/e/sleep/communications/src-update
We are aware of the inconvenience this situation may cause you. Our team is available to answer your questions at 1-855-246-9393.
