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Recall Observatory FDA recall evidence

Device product

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

Z-2123-2017

April 13, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 77124
Status
Terminated
Classification
Class II
Quantity
30 sites have the potentially affected software versions
Official record key
device-enforcement:Z-2123-2017

Official wording

Reason: Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.

Code information: Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

Distribution pattern: Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.