Z-1441-2020Class III

SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227...

Name: Z-1441-2020 SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227...
Creator: Advanced Bionics, LLC
Published: 2019-04-04
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2019-04-04 / Terminated / root cause: software

FDA source

Advanced Bionics, LLC began a recall of 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 -... on 2019-04-04. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1441-2020
Classification: Class III
Status: Terminated
Initiated: 2019-04-04
Posted: 2020-03-04
Terminated: 2022-06-27
Recalling firm: Advanced Bionics LLC
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.
Product code: MCM Implant, Cochlear
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.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: On 4/4/2019, the recalling firm sent a letter to its customers via FedEx asking that the customer return the corrupted USB drive to the firm.
Quantity in commerce: 364 versions of software
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
Product codes and lots: Lot #s: 663183 663188 663190 663858 663185 663184 663187 663186 664783 663860 664784 663859 669701 669100 669702

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1441-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1441-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)