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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 1
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:
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