SEPTEMBER 2022
PHILIPS URGENT MEDICAL DEVICE CORRECTION (MASKS WITH MAGNETS)
Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry. These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. To learn more about this Urgent Medical Device Correction use the links below.
- Read the Full Urgent Medical Device Correction Notice Online
- Download a Copy of Philips Urgent Medical Device Correction
- Download Philips Urgent Medical Device Correction FAQ
- Direct Questions About this Correction to Philips at 877-387-3311
JUNE 2021
PHILIPS VOLUNTARY RECALL INFORMATION (VARIOUS DEVICES INCLUDING DREAMSTATION)
After discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only) for various Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator) devices. For information on the recall, the registration process, a complete list of impacted products, and potential health risks, use the links below:
- Philips Respironics Sleep & Respiratory Care Devices Voluntary Recall Information
- Direct Recall Questions to Philips at 877-907-7508
- Click Here to Register Your Device for Recall Service