CARA (Computer Assisted Retinal Analysis) recall: Software Issue
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Why was CARA (Computer Assisted Retinal Analysis) recalled?
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version 4.7.2
- Product
- CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
- Recalling firm
- Diagnos Inc
- Quantity
- 1
- Distribution
- US: CA
- Recall date
- April 6, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)