Na¿da CI Q70 Sound Processor — Class II medical device recall Z-1084-2019
Terminated recall by Advanced Bionics, LLC, reported 2019-04-10, distributed in NC. The sound processors were loaded with the incorrect firmware.
| Recall number | Z-1084-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2019-02-06 |
| Classified | 2019-04-03 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2024-02-01 |
| Distributed | NC |
| Countries outside the US | AR, CA, DE, EG, IR, KW, ZA |
| Quantity | 3 sound |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07630016837814, 07630016838262, 07630016838279 |
| Serial numbers | 1013129, 1033132, 1042838 |
| Model numbers | CL-5245-120, CL-5245-140, CL-5245-150 |
Product
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Reason for recall
The sound processors were loaded with the incorrect firmware.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1084-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.