Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2123-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 13, 2016

Date Posted: May 31, 2017

Recall Number: Z-2123-2017

Event ID: 77124

Reason for Recall:

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.

Status: Terminated

Product Quantity: 30 sites have the potentially affected software versions

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.

Voluntary or Mandated:

Voluntary: Firm initiated