Recall Z-1441-2020 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
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 profou
| Date | Apr 4, 2019 |
| Status | Terminated |
| 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. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.