CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Reported: April 6, 2022 Initiated: January 11, 2022 #Z-0826-2022
Product Description
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+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.
Details
- Recalling Firm
- Diagnos Inc
- Units Affected
- 1
- Distribution
- US: CA
- Location
- Brossard, N/A
Frequently Asked Questions
What product was recalled? ▼
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179. Recalled by Diagnos Inc. Units affected: 1.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0826-2022.
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