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HiResolution" Bionic Ear System - M Battery Charger Model… recallZ-1813-2025 · Advanced Bionics, LLC · initiated Mar 5, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Bionics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]

Recall details

Recall number
Z-1813-2025
Status
Open, Classified
Initiated by the company
Mar 5, 2025
Posted by the FDA
May 22, 2025
Recalling firm
Advanced Bionics, LLC
Quantity
6 chargers
Product code
MCM
FDA submissions
P960058
Distribution
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

Product description

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

Code information (models, lots, serial numbers)

M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

24 devices cleared under P960058 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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