| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
January 11, 2022 |
| Create Date |
March 25, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0826-2022 |
| Recall Event ID |
89715 |
| 510(K)Number |
K110869
|
| Product Classification |
System, image management, ophthalmic - Product Code NFJ
|
| Product |
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 |
| Code Information |
Software Version 4.7.2 |
Recalling Firm/
Manufacturer |
Diagnos Inc
7005 Taschereau Blvd Suite 265
Brossard Canada
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
No Marketing Application |
| Action |
On 01/11/22, a recall notice was emailed to the firm's customer who was informed to immediately cease using the affected software. The only version of software cleared for commercialization is CARA v1.2.1. The customer was asked to contact a quality management representative if they had questions or comments at 1-405-678-8882 ext. 235 or mmassue@diagnos.ca |
| Quantity in Commerce |
1 |
| Distribution |
US: CA |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = NFJ and Original Applicant = DIAGNOS, INC
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