FDA Device recall Z-1441-2020
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suit…
- FDA Device
- Class III
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class III recall of SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suit… by Advanced Bionics, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1441-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-04 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Advanced Bionics |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot #s: 663183 663188 663190 663858 663185 663184 663187 663186 664783 663860 664784 663859 669701 669100 669702 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1441-2020%22
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