# FDA recall Z-1441-2020

> **Advanced Bionics, LLC** · Class III · device recall initiated 2019-04-04.

## Product

SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve.

## Reason for recall

The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed.  The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.

## Distribution

US Nationwide distribution in the sates of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI

## Key facts

- **Recall number:** Z-1441-2020
- **Recalling firm:** Advanced Bionics, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-04
- **Report date:** 2020-03-11
- **Termination date:** 2022-06-27

- **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-1441-2020

## Citation

> AI Analytics. FDA recall Z-1441-2020. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1441-2020. Source: US FDA. Licensed CC0.

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