Recall Z-1441-2020— Advanced Bionics, LLC
Class III · Terminated
Class III FDA medical device recall by Advanced Bionics, LLC, initiated 2019-04-04, terminated 2022-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Advanced Bionics, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-04
- Terminated
- 2022-06-27
- Firm location
- Valencia, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.