Philips Respironics Amara View

Philips states that Amara View "has a configuration that contains magnets that may interfere with certain implants or medical devices" (the magnetic headgear clip version). Philips Respironics issued an Urgent Medical Device Correction dated August 29, 2022 for this mask, and the FDA published a safety communication about it on September 6, 2022 ("Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices"). The updated Philips contraindication reads: "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 or valves placed in the upper limbs, torso, or higher (neck and head); CSF (cerebral spinal fluid) shunts such as a 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 (such as glaucoma or 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 (aneurysm, coronary, tracheobronchial, biliary); implantable ports and pumps (such as insulin pumps); hypoglossal nerve stimulators; devices labeled as MR (magnetic resonance) unsafe; and magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field. The updated Philips warning reads: "Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields." Philips reported 14 cases of possible interference with implanted devices, including pacemaker failure and defibrillator resets. If any of this applies to you or to anyone who sleeps near you, stop using the mask, call your doctor about a non-magnetic mask, and contact Philips Customer Care at 1-800-345-6443.