FDA Recall
Terminated
Merge Eye Station and Merge Eye Care PACS.
Recall: Z-1828-2017
·
Initiated April 4, 2016
Recall
- Recall Number
- Z-1828-2017
- Event Number
- 76844
- Firm
- Merge Healthcare, Inc.
- FEI Number
- 1000116130
- Product Code
- NFJ
- Status
- Terminated
- Root Cause
- Software in the Use Environment
- Initiated
- April 4, 2016
- Terminated
- June 22, 2020
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347
Description
Merge Eye Station and Merge Eye Care PACS.
Reason
During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
Action
The recalling firm issued a letter dated 3/28/2016 via email the week of 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter dated 7/11/2016 was issued to nonresponders.
Distribution
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
Quantity
1,627 sites potentially have the affected versions