Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.

FDA Recall Z-1084-2019 · Posted None

Recalling FirmAdvanced Bionics, LLC
Recall StatusTerminated
Product CodeMCM
Date Initiated2019-02-06
Date Terminated2024-02-01
Product Quantity3 sound processors

Reason for Recall

The sound processors were loaded with the incorrect firmware.

Firm Action

On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑