Health product recall

Cara V4

Brand(s)
Last updated

Summary

Product
Cara V4
Issue
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Cara V4 All lots. CARA V4

Issue

Potential violation of the rules and regulations related to market approval of some features of the software medical device Cara based on artificial intelligence.

Recall start date: Jan 11, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies

Diagnos Inc.

7005, Boul. Taschereau, Brossard, Quebec

Canada, J4Z 1A7

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63861