Community SDoH Alert!

URGENT – FDA recalls millions of MASKS for YOUR sleep apnea machine – due to SERIOUS SAFETY CONCERNS -The masks are for CPAP and BiPAP machines from Philips Respironics.

  • Alert date September 9, 2022

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    Millions of masks used with sleep apnea machines are currently being recalled due to safety concerns.

    Device Description
    The recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg).

    Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication

    The masks are for CPAP and BiPAP machines from Philips Respironics.

    Figure 1: Amara View Full Face Mask
    Figure 2: DreamWisp Nasal Mask
    Figure 3: DreamWear Full Face Mask
    Figure 4: Wisp and Wisp Youth Nasal Mask
    Figure 5: Therapy Mask 3100 NC/SP

    According to the Food & Drug Administration, the magnets in the mask can affect the function of the implanted metallic devices, such as brain stents, aneurysm clips and pacemakers.

    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:

    Pacemakers
    Implantable cardioverter defibrillators (ICD)
    Neurostimulators
    Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
    Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
    Aneurysm clips
    Embolic coils
    Intracranial aneurysm intravascular flow disruption devices
    Metallic cranial plates, screws, burr hole covers, and bone substitute devices
    Metallic splinters in the eye
    Ocular implants (e.g., glaucoma implants, retinal implants)
    Certain contact lenses with metal
    Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
    Magnetic denture attachments
    Metallic gastrointestinal clips
    Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
    Implantable ports and pumps (e.g., insulin pumps)
    Hypoglossal nerve stimulators
    Devices labeled as MR (Magnetic Resonance) unsafe
    Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

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