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Recall Observatory FDA recall evidence

Device product

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

Z-1085-2019

February 06, 2019

Class II

Product summary

Firm
Advanced Bionics, LLC
Event
Event 82241
Status
Terminated
Classification
Class II
Quantity
1 sound processor
Official record key
device-enforcement:Z-1085-2019

Official wording

Reason: The sound processors were loaded with the incorrect firmware.

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

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

    reason.device_software_design · v1.0.0

    incorrect firmware