Data Foundry

Medical device recalls 2019

Na¿da CL Q30 Sound Processor — Class II medical device recall Z-1083-2019

Terminated recall by Advanced Bionics, LLC, reported 2019-04-10, distributed in NC. The sound processors were loaded with the incorrect firmware.

Recall numberZ-1083-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAdvanced Bionics, LLC, Valencia, CA, United States
Recall initiated2019-02-06
Classified2019-04-03
Reported by FDA2019-04-10
Terminated2024-02-01
DistributedNC
Countries outside the USAR, CA, DE, EG, IR, KW, ZA
Quantity4 sound
Reason classessoftware
UPC / GTIN / UDI-DI07630016829710, 07630016838057, 07630016838071
Serial numbers1047481, 1047482, 1047584, 1082276
Model numbersCL-5260-120, CL-5260-140, CL-5260-150

Product

Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

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-1083-2019. 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.