URGENT Medical Device Correction Notification:

Respironics has issued an urgent medical device correction to notify patients about an update to existing "contraindications' and 'warning' of several masks containing magnets used with CPAP/BiPap devices.  The following masks are impacted:

Please read the official Philips Respironics notification to patients here. (PDF, 2MB)

The affected masks contain magnets that can potentially affect the functioning and/or induce the movement/dislocation of medical implants or medical devices that can be impacted by the magnetic fields.  if the mask magnets are placed less than 6 inches (approx. 15.24 cm) away from a metallic implant or device the magnets may cause the device to not perform as intended, which may result in a serious injury.  See the Contraindication and Warning in this notice for additional details.

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:

If you meet the criteria for a contraindication, ChelseaCare HME has several solutions to offer.  Please call one of our stores and we can work with you and your healthcare provider to help facilitate a replacement clip or mask. 

Patients with questions may go to the Phillips website Updated instructions and labeling of specific sleep therapy masks - News | Philips  or 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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