Diagnos Inc 2022-04-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0826-2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall
Issued April 6, 2022 · Diagnos Inc
In April 2022, Diagnos Inc recalled the CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Diagnos Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Diagnos Inc
- Category
- Health
- Recall date
- April 6, 2022
- Units affected
- Not reported
- Sold at
- US: CA
- Recall number
- FDA-Z-0826-2022
- Made in
- Canada
- Issuing agency
- FDA
In context
- Diagnos Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.