Canonical text (the exact bytes fingerprinted)

TRUVACE RECORD VERSION
record: TRV-2026-1375
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-10-14T22:02:39.303723Z
status: published
lens: p_space
sector: health
headline: Diagnos Inc recalls an AI-enabled medical device
dek: 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.
gain_title: (none)
problem_title: 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.
trace_subject: (none)
gain_reading: (none)
gain_evidence: (none)
problem_reading: 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.
problem_evidence: some features, based on artificial intelligence, that potentially lack appropriate market approval | it is recommended to use a specific prior software version
quick_read: A recall record dated March 2022 covers CARA (Computer Assisted Retinal Analysis), a retinal analysis system sold by Diagnos Inc. The stated reason is that some software features rely on artificial intelligence and may not have the market approval they need.

The record shows regulators and manufacturers treating AI features in clinical software as items needing explicit authorization. The text does not say whether any patient was harmed, how many units were affected, or whether the features performed poorly, so the practical clinical impact is unknown.
limitation: 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.
tag: Evidence-backed problem
key_points: The recalled product is CARA, a Computer Assisted Retinal Analysis system. | The recall reason concerns AI-based software features that potentially lack appropriate market approval. | The recommended corrective step is to use a specific prior software version. | The record lists a product identifier referencing software version 4.7.2.
rundown: The source is a government recall entry for a medical device, with a publication date of 2022-03-25. It identifies the device as a retinal analysis system and lists a product ID that includes a software version reference.

The wording is cautious: the AI features potentially lack appropriate approval, rather than being stated as definitively unapproved or unsafe. The remedy given is not removal of the product but a recommendation to use a specific earlier software version.

The supplied text contains no information on clinical accuracy, injuries, the number of devices affected, or how the prior version differs from the recalled one.
sources:
- government | FDA medical-device recall 192285 | https://api.fda.gov/device/recall.json?search=cfres_id%3A%22192285%22&sort=event_date_created%3Adesc&limit=1 | 2022-03-25
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