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U.S. Department of Health and Human Services

Class 3 Device Recall Soundwave Professional Suite Software 3.2

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 Class 3 Device Recall Soundwave Professional Suite Software 3.2see related information
Date Initiated by FirmApril 04, 2019
Create DateMarch 04, 2020
Recall Status1 Terminated 3 on June 27, 2022
Recall NumberZ-1441-2020
Recall Event ID 84800
PMA NumberP960058 
Product Classification Implant, cochlear - Product Code MCM
ProductSoundWave 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.
Code Information Lot #s:  663183 663188 663190 663858 663185 663184 663187 663186 664783 663860 664784 663859 669701 669100 669702
Recalling Firm/
Manufacturer		 Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information ContactCarol Abernathy
661-362-7580
Manufacturer 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.
FDA Determined
Cause 2		Software in the Use Environment
ActionOn 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 Commerce364 versions of software
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = MCM
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