Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 2 Recall
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts
Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 2 Recall
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts
Advanced Bionics, LLC - Soundwave Professional Suite Software 3.2 - Class 3 Recall
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2020 Category: Medical Devices Source Type: alerts
