Z-0826-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2022
- Initiation Date
- January 11, 2022
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Reason for Recall
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
Distribution Pattern
US: CA
Code Information
Software Version 4.7.2