FDA DeviceClass IINotable

FDA Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog

Name: FDA Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog
Brand: Advanced Bionics, LLC

Date: 2026-03-11

Brand: Advanced Bionics, LLC

Category: Medical Device

FDA Class: Class II

Description

Behind-the-ear sound processer packaging label is different then included product.

Hazard

Behind-the-ear sound processer packaging label is different then included product.

Remedy

2 units

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