On June 14, Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The recall is in response to potential health risks related to the sound abatement foam component in these devices. The majority of the affected devices are in the first-generation DreamStation product family. Read the Philips press release for more information.
- Clinicians can view the AASM guidance in response to Philips recall of PAP devices for additional information.
- The AASM also offers guidance for patients and FAQs for patients on the Sleep Education website
Potential Foam Degradation
Philips reports that it has received a low complaint rate (0.03% in 2020). However, Philips determined based on testing that there are possible risks to users related to the type of foam used in these devices. The risks include that the foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user. Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.
Advice for Patients and Customers
In November 2021, Philips updated the guidance in its recall notification to align with recommendations in an FDA safety communication. The updated recall notification advises patients using bi-level PAP and CPAP devices to consult with their physician on a suitable treatment plan. Patients, physicians and durable medical equipment (DME) suppliers can call Philips at 877-907-7508 for additional support.
Repair and Replacement
On Sept. 1, Philips announced that it had received authorization from the FDA to begin its repair and replacement programs for recalled devices. The sound abatement foam in recalled devices will be replaced with a new material. The company also is replacing some DreamStation CPAP devices with DreamStation 2 devices. Philips noted that it intends to complete the repair and replacement programs within approximately 12 months.
To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. The website will give you instructions on how to locate the serial number of your device. It also will guide you through the registration process. You can contact Philips at SRC.Support@philips.com or (877) 907-7508 for additional help.
Updated Dec. 7, 2021