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Advanced Bionics, LLC: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Medical DevicesSource: FDA (device) · Date: 2026-03-11

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Advanced Bionics, LLC
Product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Reason / hazard
Behind-the-ear sound processer packaging label is different then included product.
Classification
Class II
Status
Ongoing
Distribution / sold at
Unknown
Recall initiated
2025-11-27
Code info
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Valencia
State
CA
Country
United States
Event id
98161
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