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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Cardio

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  Class 2 Device Recall Merge Cardio see related information
Date Initiated by Firm April 04, 2016
Date Posted March 03, 2017
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-1403-2017
Recall Event ID 76590
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.
Code Information Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service & Support
Manufacturer Reason
for Recall
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
FDA Determined
Cause 2
Software design
Action Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
Quantity in Commerce 110 sites potentially have the affected versions
Distribution Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
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