Device 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.
Z-1084-2019
Product summary
- Event
- Event 82241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 sound processors
- Official record key
device-enforcement:Z-1084-2019
Official wording
Reason: The sound processors were loaded with the incorrect firmware.
Code information: Model Cl-5245-120 - Serial number 1042838, UDI (01)07630016837814(11)150729(21)1042838; Model Cl-5245-140 - Serial number 1013129, UDI (01)07630016838262(11)181030(21)1013129; and Model Cl-5245-150 - Serial number 1033132, UDI (01)07630016838279(11)170525(21)1033132.
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.
Derived failure modes
-
Device software or design
incorrect firmware