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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Cardio software

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  Class 2 Device Recall Merge Cardio software see related information
Date Initiated by Firm April 13, 2016
Date Posted May 22, 2017
Recall Status1 Terminated 3 on July 17, 2017
Recall Number Z-2123-2017
Recall Event ID 77124
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Versions 10.0, 10.0.1, 10.1, 10.1.1,, and 10.1.2.
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = CAMTRONICS MEDICAL SYSTEMS