Recall Z-1084-2019 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
| Date | Feb 6, 2019 |
| Status | Terminated |
| Reason | The sound processors were loaded with the incorrect firmware. |
| Root cause | Process control |
| Action | On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route. |
| Quantity | 3 sound processors |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.