SoundWave Professional Suite Software 3 — Class III medical device recall Z-1441-2020
Terminated recall by Advanced Bionics, LLC, reported 2020-03-11, distributed nationwide. The manufacturer received complaints that customers were attempting to install the fitting software using the
| Recall number | Z-1441-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2019-04-04 |
| Classified | 2020-03-04 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2022-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 364 versions |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07630016853227 |
| Lot numbers | 663183, 663184, 663185, 663186, 663187, 663188, 663190, 663858, 663859, 663860, 664783, 664784, 669100, 669701, 669702 |
| Model numbers | 058-023-32085, CI-6055-014 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1441-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.