FDA DeviceClass IINotable

FDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Numbe

Date: 2026-05-06
Brand: Advanced Bionics, LLC
Category: Medical Device
FDA Class: Class II

Description

The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

Hazard

The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

Remedy

45173

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