medical Class II Updated 2020-05-27

Advanced Bionics, LLC recalls AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocu

Recalled Product

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.

Hazard / Issue

hearing performance degradation due to body-fluid entering the device.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Numbers: CI 1601 04 - HiRes Ultra 3D with HF Mid-Scala Electrode CI 1601 05 - HiRes Ultra 3D with HF SlimJ Electrode Lot Numbers - 1000000 thru 1999999.
View official government recall

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