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Merge Cardio software. The firm name on the label is Merge… recallZ-2123-2017 · Merge Healthcare, Inc. · initiated Apr 13, 2016

Class II Terminated All recalls posted in May 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Software design

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2123-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 13, 2016
Posted by the FDA
May 22, 2017
Recalling firm
Merge Healthcare, Inc.
Quantity
30 sites have the potentially affected software versions
Product code
LLZ
FDA submissions
K051649
Distribution
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

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.

Code information (models, lots, serial numbers)

Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

Other devices under the same FDA submission

4 devices cleared under K051649 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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