CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Summary
The FDA issued a Class II for CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D by Diagnos Inc. Reason: Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is reco.
Details
Source
Device Recall
External ID
Z-0826-2022
Action Date
2022-04-06
Status
Terminated
Category
device
Product Description
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Lot/Code Info: Software Version 4.7.2
Quantity Affected: 1
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.
Distribution
US: CA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-11
Company
Brossard, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diagnos Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diagnos Inc have FDA actions?
This is the only FDA action we have on record for Diagnos Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0826-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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