Home / Recalls / Advanced Bionics, LLC / Z-1084-2019

Z-1084-2019 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
3 sound processors

Product Description

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.

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

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.

Other recalls by Advanced Bionics, LLC

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  • Z-1813-2025 Class II — HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 (March 5, 2025)
  • Z-0487-2021 Class III — AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used (September 26, 2020)
  • Z-0486-2021 Class III — AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used (September 26, 2020)
  • Z-2032-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - (February 17, 2020)
  • Z-2033-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: (February 17, 2020)
  • Z-1441-2020 Class III — SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, U (April 4, 2019)
  • Z-1259-2020 Class III — HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF C (March 18, 2019)
  • Z-1085-2019 Class II — Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. (February 6, 2019)
  • Z-1083-2019 Class II — Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model (February 6, 2019)