CLASS II Device recall · Reported 6 Apr 2022 · FDA Enforcement Report
CARA (Computer Assisted Retinal Analysis), Product ID recalled
Diagnos is recalling CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179, distributed in California. The recall was initiated on 11 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0826-2022
- FDA event ID
- 89715
- Recalling firm
- Diagnos, Brossard, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2022
- FDA classified
- 25 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 11 Jan 2022 | Recall initiated by company | |
| 25 Mar 2022 | Classified by FDA | +73 days |
| 6 Apr 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Where it was distributed
US: CA
Questions about this recall
Is CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 recalled?
Yes. Diagnos recalled CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 on 11 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0826-2022.
Why was it recalled?
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.
Which lots are affected?
Software Version 4.7.2
Where was it sold?
US: CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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