Advanced Bionics, LLC
Device Recalls (Class II)
Class II
Z-1493-2026
·
20260311
·
Ongoing
Product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Reason for Recall
Behind-the-ear sound processer packaging label is different then included product.
Distribution
Unknown
Source: openFDA Enforcement API