Recall & Response Updates

Philips Respironics: Certain Masks for BiPAP, CPAP Machines

On September 6, 2022, Philips Respironics issued a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling.

IMPORTANT: Please be aware that the masks affected by this recall may be unavailable for ordering, even for patients without contraindications, until Philips Respironics has completed the re-labeling of the product and released the affected product for continued distribution to patients. Patients affected in this manner may be offered an alternative mask during the normal supply re-ordering process.

What should I do now?

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Read the Notice. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication – see notice here. Additional links and resources can be in the “Resources & Links” section at the bottom of this page or on the manufacturer’s website.

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If you have contraindications, call your DME Provider. Patients with a contraindication (as listed in the Philips Notice) should contact their current Durable Medical Equipment (DME) provider to discuss options for an alternative mask that can be used with your device. When contacting our offices (see our locations for contact info), please let our Call Center attendant know that you are calling regarding the Philips Mask Recall.

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For all other questions, contact Philips Respironics. Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options.

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Report Adverse Events. Report any adverse events experienced with the use of masks containing magnetic clips should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

Updates

Tuesday, September 9, 2022

Philips Respironics issues Frequently Asked Questions (FAQs) following its alert to customers worldwide of updated instructions and labeling of specific sleep therapy masks that contain magnetic headgear clips due to the potential risk of serious injury.

Tuesday, September 6, 2022

Philips Respironics alerts customers worldwide of updated instructions and labeling of specific sleep therapy masks that contain magnetic headgear clips due to the potential risk of serious injury. 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.