The Recall Desk
HighFDA (Devices)·Z-0826-2022·Announced 2022-04-06

Retinal Analysis Software with Potentially Unapproved AI Features Recalled

Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a diagnostic tool with AI features that potentially lack appropriate market approval. Although no illnesses or injuries have been reported, this represents a risk-of-harm situation involving regulatory non-compliance.

Plain-English summary

Diagnos Inc is recalling CARA (Computer Assisted Retinal Analysis) software version 4.7.2. The retinal analysis system contains artificial intelligence-based features that potentially lack appropriate FDA market approval.

Affected users should discontinue use of version 4.7.2 and revert to a prior software version. The product was distributed to users in California.

The recalled product

Product
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Manufacturer
Diagnos Inc
Category
Medical Device — Diagnostic Software / Retinal Analysis
Hazard
  • unapproved-ai-features

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software Version 4.7.2

Distribution

Distributed in 1 state:

  • CA

Related recalls

Same category