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Recall Observatory FDA recall evidence

Device product

Merge Eye Station and Merge Eye Care PACS.

Z-1828-2017

April 04, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76844
Status
Terminated
Classification
Class II
Quantity
1,627 sites potentially have the affected versions
Official record key
device-enforcement:Z-1828-2017

Official wording

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.

Code information: All versions

Distribution pattern: Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.