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.
This recall has been terminated (originally issued May 22, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 13, 2016
- Posted
- May 22, 2017
- Terminated
- July 17, 2017
- Recall Number
- Z-2123-2017
- Quantity
- 30 sites have the potentially affected software versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
Lot / Code Info
Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.
Root Cause
Software design
Action Taken
The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail recall@merge.com.