Advanced Bionics, LLC Recalls

1 recall on record in the United States

medical: 1
medical Class II
2026-05-06

Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M

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.

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