Z-1441-2020 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- April 4, 2019
- Termination Date
- June 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 364 versions of software
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.
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.
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
Code Information
Lot #s: 663183 663188 663190 663858 663185 663184 663187 663186 664783 663860 664784 663859 669701 669100 669702