fda_recall · device_recall · high
Advanced Bionics, LLC — Class II recall: Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak…
- Event date
- 2026-05-06 00:00:00Z
- Observed
- 2026-07-09 22:52:48Z
- Source ID
- Z-1950-2026
- Payload hash
- 939ec6fd976551305c887c21…
Summary
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. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.