Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1493-2026

November 27, 2025

Class II

Product summary

Firm
Advanced Bionics, LLC
Event
Event 98161
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1493-2026

Official wording

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

Code information: Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

Distribution pattern: Unknown

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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