Device 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.
Z-1083-2019
Product summary
- Event
- Event 82241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 sound processors
- Official record key
device-enforcement:Z-1083-2019
Official wording
Reason: The sound processors were loaded with the incorrect firmware.
Code information: Model Cl-5260-120 - Serial number 1047584, UDI (01)07630016838057(11)180309(21)1045784; Model Cl-5260-140 - Serial number 1047481, UDI (01)07630016829710(11)151208(21)1047481; and Serial number 1047482, UDI (01)07630016829710(11)151208(21)1047482; and Model Cl-5260-150 - Serial number 1082276, UDI (01)07630016838071(11)180925(21)1082276.
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