CLASS III Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
SoundWave Professional Suite recalled by Advanced Bionics
Advanced Bionics is recalling SoundWave Professional Suite, distributed nationwide in the US. The recall was initiated on 4 Apr 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1441-2020
- FDA event ID
- 84800
- Recalling firm
- Advanced Bionics, Valencia, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Apr 2019
- FDA classified
- 4 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hearing Aids
Timeline
| 4 Apr 2019 | Recall initiated by company | |
| 4 Mar 2020 | Classified by FDA | +335 days |
| 11 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Is SoundWave Professional Suite recalled?
Yes. Advanced Bionics recalled SoundWave Professional Suite on 4 Apr 2019. The recall is Class III and its status is Terminated. Recall number Z-1441-2020.
Why was it 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.
Which lots are affected?
Lot #s: 663183 663188 663190 663858 663185 663184 663187 663186 664783 663860 664784 663859 669701 669100 669702
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Bionics
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled | Advanced Bionics | Packaging Defects | CA |
| Device | CLASS II | HiResolution" Bionic Ear System - M Battery Charger recalled | Advanced Bionics | Packaging Defects | 6 states |
| Device | CLASS III | AB PowerCel 230 (velvet black) recalled by Advanced Bionics | Advanced Bionics | Labeling Errors | Nationwide |
Other Hearing Aids recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | See RES for full list recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Chp Cochlear Supplement Cds recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Device Malfunction | Nationwide |