CPAP, BiPAP, and Ventilator Recall Notification
On June 14, Philips Respironics initiated a voluntary recall for specific continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP), and mechanical ventilator devices due to potential health risks associated with deterioration of internal sound abatement foam. As the foam disintegrates, it may cause particles to enter the air tube and potentially reach the patient.
www.philips.com/SRC-update lists the devices affected by the recall. Please go to the website to check if your device is affected.
We wish to emphasize that this is a voluntary recall from Philips out of an abundance of caution to patients who rely upon the impacted devices. It has not reached the level of a recall under the U.S. Food and Drug Administration. Sleep Lab experts, Pulmonary Medicine providers, Internal Medicine physicians and such professional societies as the American Academy of Sleep Medicine and American Thoracic Society have collaborated regarding the risks and benefits of continued use of these devices in the face of this recall. Potential health risks include airway inflammation, skin, eye and respiratory tract irritation, headache, asthma, toxic and carcinogenic effects, cough, chest pressure or sinus infection. Philips reports that the foam-related complaint rate was very low (0.03%) and there have been no associated deaths to date.
While the manufacturer’s website advises patients to contact their respective physicians, we are offering you general guidance as the medical community awaits more specific scientific information from the company.
- If you work in safety-critical positions such as professional drivers, pilots or heavy equipment operators, it is recommended that you continue use of your device.
- If you have severe sleep apnea, severe breathing difficulties or were very sleepy during the daytime prior to treatment, have significant lung disease, heart disease or neurologic conditions, it is recommended that you continue use your device.
- If you have mild-moderate sleep apnea without excessive daytime sleepiness, you may consider to stop using your device and make an appointment with your provider to discuss alternative options of treatment.
- Do not use any ozone-based cleaners. Continue to follow the manufacturer’s cleaning instructions for your device.
We urge all patients who may be using a Philips Respironics device to log on to the Philips website at: www.philips.com/SRC-update. This website will allow you to input the serial number of your device and open a claim if your device is part of the recall. You may also receive more information about the Philips Respironics recall by calling (877) 907-7508. We regret that FBCH is currently unable to obtain replacement device equipment for our beneficiaries. In the meantime, we ask that you continue any specific behavioral strategies you were recommended to follow such as weight loss, exercise and avoidance of alcohol and sedatives before bedtime.
We will continue to update these recommendations as we receive more information. Again, we thank you for your patience and understanding as we work to ensure the safety of our beneficiaries.