FDAFDA · Food and drugs·Recall number Z-0826-2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Published April 6, 2022 · Recall initiated: January 11, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Diagnos Inc
- Distributor
- US: CA
- Lot
- Software Version 4.7.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.