Merge Eye Station and Merge Eye Care PACS.
This recall has been terminated (originally issued April 4, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Terminated
- June 22, 2020
- Recall Number
- Z-1828-2017
- Quantity
- 1,627 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
Lot / Code Info
All versions
Root Cause
Software in the Use Environment
Action Taken
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.
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