Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Numbe
- Recall date
- 2026-05-06
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
45173
Product 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.