HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

FDA device recall Z-1813-2025 · posted 2025-05-22 · Open, Classified

Recall details

Recalling firm

Advanced Bionics, LLC

Reason for recall

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Action taken

On 03/06/2025, customer service informed customers via telephone call of a distribution error. An updated "URGENT: Medical Device Recall Notification will be communicated to customers on or about 04/09/2025, via email. This updated notification will inform them that upon further review/investigation, it was identified that the individual package label was for the Marvel M Battery Charger (CI-5607), however the product within the package was a Naida CI PowerCel Charger (CI-5605). Customer are informed that: 1. The mislabeled battery charger they received was from lot either Lot Numbers: 410488967 and/or 410488966 Customers are instructed to: 2. Return the affected chargers to Advance Bionics. Advance Bionics will provide the correct charger to customer and will confirm receipt and return of the affected chargers. For questions contact customer service at 877-829-0026 or email Customerservice@advancebionics.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MCM

Quantity affected

6 chargers

Distribution

U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

Date initiated

2025-03-05

Date posted

2025-05-22

Location

Valencia, CA