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Recall Observatory FDA recall evidence

Device product

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

Z-1246-2017

March 28, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 75914
Status
Terminated
Classification
Class II
Quantity
1,627 sites potentially have the affected versions
Official record key
device-enforcement:Z-1246-2017

Official wording

Reason: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Code information: Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1

Distribution pattern: Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)