Z-1085-2019 Class II Terminated
FDA device recall Z-1085-2019 was initiated by Advanced Bionics, LLC on February 6, 2019 and is designated Class II. Reason for recall: The sound processors were loaded with the incorrect firmware. The recall status is terminated (terminated February 1, 2024). Affected quantity: 1 sound processor.
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.