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.
Reported: May 31, 2017 Initiated: April 13, 2016 #Z-2123-2017
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.
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 30 sites have the potentially affected software versions
- Distribution
- Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merge Healthcare, Inc.. Units affected: 30 sites have the potentially affected software versions.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2123-2017.
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