Home / Recalls / Advanced Bionics, LLC / Z-1085-2019

Z-1085-2019 Class II Terminated

Recalled by Advanced Bionics, LLC — Valencia, CA

Recall Details

Product Type
Devices
Report Date
April 10, 2019
Initiation Date
February 6, 2019
Termination Date
February 1, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 sound processor

Product Description

Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.

Reason for Recall

The sound processors were loaded with the incorrect firmware.

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.

Code Information

Serial number 1066444, UDI (01)07630016838118(11)180725(21)1066444.

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  • Z-1259-2020 Class III — HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF C (March 18, 2019)
  • Z-1083-2019 Class II — Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model (February 6, 2019)
  • Z-1084-2019 Class II — Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model (February 6, 2019)