Reported Mar 11, 2020 · Terminated
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical…
Advanced Bionics, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Bionics, LLC · 28515 Westinghouse Pl · Valencia, CA · 91355-1398
Is this the product you have?
SoundWave Professional Suite Software 3.2Ref CI-6055-014SPN 058-023-32085
- UDI
(01)07630016853227Logical SoundWave Professional Suite 3.2
- CE 0123 - Product UsageSoundwave 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
- Lot codes and dates
- Lot #s:
663183663188663190663858663185663184663187663186664783663860664784663859669701669100669702
- Lot #s:
- Amount recalled
- 364 versions of software
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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