# FDA recall Z-0486-2021

> **Advanced Bionics, LLC** · Class III · device recall initiated 2020-09-26.

## Product

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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0486-2021
- **Recalling firm:** Advanced Bionics, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-26
- **Report date:** 2020-12-02
- **Termination date:** 2023-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2021

## Citation

> AI Analytics. FDA recall Z-0486-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0486-2021. Source: US FDA. Licensed CC0.

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