Z-0486-2021Class III

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following...

Name: Z-0486-2021 AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following...
Creator: Advanced Bionics, LLC
Published: 2020-09-26
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2020-09-26 / Terminated / root cause: labeling and UDI

FDA source

Advanced Bionics, LLC began a recall of AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI... on 2020-09-26. FDA classified it as Class III and gives the reason as "Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0486-2021
Classification: Class III
Status: Terminated
Initiated: 2020-09-26
Posted: 2020-11-25
Terminated: 2023-05-04
Recalling firm: Advanced Bionics LLC
Product: AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260) for cochlear implant.
Product code: MCM Implant, Cochlear
Reason for recall: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 9/26/2020 Advanced Bionics sent a "Field Correction Notification" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees. In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery.
Quantity in commerce: 53 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.
Product codes and lots: 410079020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0486-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0486-2021	Class III	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25
Z-0487-2021	Class III	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)