Naida CI Q30 recallZ-1083-2019 · Advanced Bionics, LLC · initiated Feb 6, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Bionics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The sound processors were loaded with the incorrect firmware.
FDA root cause category: Process control
What the company is doing
On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
Recall details
- Recall number
- Z-1083-2019
- Status
- Terminated
- Initiated by the company
- Feb 6, 2019
- Recalling firm
- Advanced Bionics, LLC
- Quantity
- 4 sound processors
- Product code
- MCM
- FDA submissions
- P960058
- Distribution
- Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
Product description
Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Code information (models, lots, serial numbers)
Model Cl-5260-120 - Serial number 1047584, UDI (01)07630016838057(11)180309(21)1045784; Model Cl-5260-140 - Serial number 1047481, UDI (01)07630016829710(11)151208(21)1047481; and Serial number 1047482, UDI (01)07630016829710(11)151208(21)1047482; and Model Cl-5260-150 - Serial number 1082276, UDI (01)07630016838071(11)180925(21)1082276.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Naida CI Q30 CI-5260-140Advanced Bionics, LLC · IMPLANT, COCHLEAR1 recall0 reports
- Naida CI Q30 CI-5260-120Advanced Bionics, LLC · IMPLANT, COCHLEAR1 recall0 reports
- Naida CI Q30 CI-5260-150Advanced Bionics, LLC · IMPLANT, COCHLEAR1 recall0 reports
Product lines
Other devices under the same FDA submission
22 devices cleared under P960058 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Advanced Bionics AG · Implant, Cochlear2,918 reports
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04Advanced Bionics AG · Implant, Cochlear1 death931 reports
- HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05Advanced Bionics AG · Implant, Cochlear795 reports
- HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05Advanced Bionics AG · Implant, Cochlear335 reports
- HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04Advanced Bionics AG · Implant, Cochlear315 reports
- HiRes 90K™ Advantage CI HiFocus™ 1j Electrode CI-1500-01Advanced Bionics AG · Implant, Cochlear280 reports
- HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05Advanced Bionics, LLC · Implant, cochlear1 death257 reports
- HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05Advanced Bionics AG · Implant, Cochlear254 reports
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04Advanced Bionics, LLC · Implant, cochlear1 recall149 reports
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04Advanced Bionics AG · Implant, Cochlear195 reports
- HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05Advanced Bionics AG · Implant, Cochlear178 reports
- HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04Advanced Bionics AG · Implant, Cochlear1 recall127 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82241).
- Z-1084-2019 · TerminatedNada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
- Z-1085-2019 · TerminatedNada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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