Advanced Bionics, LLC: Medical Device Recall in 2020 - (Recall #: Z-0486-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

Product Classification:

Class III

Date Initiated: September 26, 2020
Date Posted: December 2, 2020
Recall Number: Z-0486-2021
Event ID: 86536
Reason for Recall:

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Status: Terminated
Product Quantity: 53 units
Code Information:

410079020

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated