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Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D
… their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or … device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of … contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be …
Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury
… 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 …
Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants
… embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear … embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear …
FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella
… was provided with an opportunity to request an informal hearing. The company did not respond within the timeframe … therefore waiving its opportunity for an informal hearing, and the agency ultimately issued the mandatory …
GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings
… constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention. As of the date of …
ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices
… coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, …