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Diagnos 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.

By the Truvace desk1 min read1 sourceOfficial statisticsTRV-2026-1375· cite & verify
Diagnos Inc recalls an AI-enabled medical device
"CRE-003 OphaGo - Retinal Imaging Adapter - Huced Despro ITS" by Djoko Kuswanto is marked with CC0 1.0. To view the terms, visit https://creativecommons.org/publicdomain/zero/1.0/.

In brief

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.

Main points

  1. The recalled product is CARA, a Computer Assisted Retinal Analysis system.
  2. The recall reason concerns AI-based software features that potentially lack appropriate market approval.
  3. The recommended corrective step is to use a specific prior software version.
  4. The record lists a product identifier referencing software version 4.7.2.

The problem

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 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

  1. GovernmentFDA medical-device recall 1922852022-03-25

The debate