Advanced Bionics Recalls SoundWave Professional Suite Software 3.2
Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because the installation process fails when using the supplied USB drive, though current software versions remain functional.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the source explicitly states that the installation failure has no impact on the current software version and users can continue programming devices, indicating a low-risk issue with no reported harm.
Plain-English summary
Advanced Bionics, LLC is recalling SoundWave Professional Suite Software 3.2 (Ref CI-6055-014, SPN 058-023-32085) due to installation failures. The recall involves 364 versions of the software distributed nationwide in the United States.
The manufacturer received complaints that customers attempting to install the fitting software using the supplied USB drive received an error message and the installation failed. This issue affects the installation process only; it does not impact the current version of the software, and users are able to continue programming devices with the current software version.
Healthcare professionals using this software to program Advanced Bionics sound processors for cochlear implants should be aware of the installation issue. The source text does not specify further consumer actions beyond the fact that current software versions remain functional for device programming.
The recalled product
- 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 A
- Manufacturer
- Advanced Bionics, LLC
- Category
- Medical Device — Software
- Affected units
- 364
Distribution
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