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Lower risk Medical device recall · FDA · Published April 4, 2019

Advanced Bionics SoundWave Software 3.2 Installation Errors

Advanced Bionics recalls SoundWave Professional Suite Software 3.2 due to installation errors when using the USB drive. Users can continue programming devices with current software versions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1441-2020Medical deviceAdvanced Bionics ›
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Contact the company

Recalling firmAdvanced Bionics, LLC28515 Westinghouse Pl · Valencia, CA 91355-1398
✎ GovInfoNow plain-language explainer

Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because customers reported installation failures when using the supplied USB drive. This issue does not affect the current software version, so users can continue programming their devices with the existing software. Read more at govinfonow.com/recall/68491-advanced-bionics-soundwave-software-3-2-installation-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/68491-advanced-bionics-soundwave-software-3-2-installation-errors · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1441-2020

Cite this page

“Advanced Bionics SoundWave Software 3.2 Installation Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68491-advanced-bionics-soundwave-software-3-2-installation-errors. Based on FDA recall #Z-1441-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1441-2020%22&limit=1).

The FDA announced on April 4, 2019, that Advanced Bionics, LLC voluntarily recalled SoundWave Professional Suite Software 3.2 due to installation failures when using the supplied USB drive. The agency issued recall number Z-1441-2020 for the device.

How to tell if you have it

  • SoundWave Professional Suite Software 3.2
  • Ref CI-6055-014
  • SPN 058-023-32085
  • UDI: (01)07630016853227
  • UPC 07630016853227
  • Lot #s: 663183, 663188, 663190, 663858, 663185, 663184, 663187, 663186, 664783, 663860, 664784, 663859, 669701, 669100, 669702

The hazard

The manufacturer received complaints that customers attempting to install the fitting software using the supplied USB drive received an error message and failed installation. The record states this failed installation has no impact on the current version of the software, and users can continue programming devices with the current version.

Context

GovInfoNow's records show Advanced Bionics, LLC has 8 other recalls on record since February 6, 2019. Other recent recalls include the HiResolution Bionic Ear System Recall regarding an incorrect shelf-life expiration date (April 30, 2026) and the HiResolution Bionic Ear System Battery Pak recall for a non-tamperproof door (March 23, 2026). A November 27, 2025, recall addressed packaging label mismatches for the HiResolution Sky CI M90 Sound Processor.

How to tell if you have this one

Check for the SoundWave Professional Suite Software 3.2 version with reference number CI-6055-014, serial number SPN 058-023-32085, or lot numbers listed in the recall notice. This software is used by healthcare professionals for cochlear implant programming.

  • Brand
    Advanced Bionics
  • Product
    SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your software version by checking the product label or documentation for SoundWave Professional Suite 3.2 with reference number CI-6055-014.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 40 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Apr 4, 201912. FDA classified it Class III: Mar 4, 202023. Published in FDA’s Enforcement Report: Mar 11, 202034. FDA terminated the recall: Jun 27, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Advanced Bionics recalls

Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110;
March 23, 2026Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
November 27, 2025

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1441-2020 (April 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1441-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA