Advanced Bionics, LLC: Medical Device Recall in 2020 - (Recall #: Z-1441-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: April 4, 2019

Date Posted: March 11, 2020

Recall Number: Z-1441-2020

Event ID: 84800

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.

Status: Terminated

Product Quantity: 364 versions of software

Code Information:

Lot #s: 663183 663188 663190 663858 663185 663184 663187 663186 664783 663860 664784 663859 669701 669100 669702

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated