aceDiagnos Inc recalls an AI-enabled medical device
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall reason: 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.
AI-based features in the CARA retinal analysis software potentially lacked appropriate market approval, leading to a recommendation to revert to a specific prior software version.
The record only says the AI features potentially lack market approval and gives no evidence of patient harm, device performance problems, or the scale of the recall.
Evidence
- GovernmentFDA medical-device recall 1922852022-03-25
How should this claim be treated?
Truvace Impact Record TRV-2026-1375, v1: “Diagnos Inc recalls an AI-enabled medical device.” Truvace, 2026-10-14. /record/TRV-2026-1375 (accessed at citation time). sha256 ddfdaccce508ea93…
Calibration history
Every change to this record since certification, in the open. None yet — the reading has held since it entered the record.
Certified into the record
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