Philips issues Dreamstation CPAP recall notification

Philips has 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, and the recently launched DreamStation 2 is not affected by the issue.

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 headaches and respiratory problems. The foam also may off-gas certain chemicals. Philips indicates that this foam degradation may be exacerbated by the 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

Philips advises patients and customers to take the following actions:

• For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work 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 the recall notification.

Patients can call Philips at 877-907-7508 for additional support.

For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.