On September 6, 2022, Philips Respironics, on its press release, alerted its patients worldwide on revised instructions on their CPAP masks, that contain magnetic headgear clips or straps due to the potential risk of serious injury it may cause. Magnetic headgear clips are generally being used to attach and detach the CPAP masks headgear straps more easily.

The FDA issued a recall and safety notice that these masks could potentially cause injury or death. They also indicated that this announcement is considered a Class I “recall” as recalls may not be limited to ‘removal of the product from the field’ but also ‘the correction of product in the field’.

The FDA identified that the impacted mask includes Amara View Full Face Mas, Dream Wisp Nasal Mask, Dreamwear, Full Face Mask, Wisp and Youth Nasal Mask, and Therapy Mask 3100 NC/SP, with distribution dates from January 1, 2015 to September 9, 2022. You can check the affected masks and their serial and model numbers here

Philips Respironics stated that these masks with magnetic clips are ‘safe’ to use and patients may continue to use them according to the updated instructions and labeling if patients or people near them do not have implanted metallic medical devices or metallic objects in the body. They also added that the ‘voluntary notification’ aims to represent a new and industry-leading practice as these magnetic headgear clips are commonly used in the sleep therapy industry today. Philips Respironics firmly assert that this notification should not stop their customers from using their masks, but only if the implanted metallic medical device/metallic objects are contraindicated against their mask’s magnets. Here is the list:

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers, and bed partners that may be in close vicinity to patients using the masks that have implanted devices that may be affected by magnets, including but not limited to: