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U.S. Department of Health and Human Services

Class 2 Device Recall Fusion Workstation

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  Class 2 Device Recall Fusion Workstation see related information
Date Initiated by Firm October 28, 2011
Create Date October 20, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-0294-2017
Recall Event ID 75425
510(K)Number K983401  
Product Classification System, image processing, radiological - Product Code LLZ
Product Fusion Workstation.; Indicated for the transmission and review of radiological images.
Code Information Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.
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
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
FDA Determined
Cause 2
Software design
Action The recalling firm initiated phone calls to affected sites beginning 1/30/2016.
Quantity in Commerce 13 sites potentially hae the affected version
Distribution Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
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 = ML STRATEGIES, INC.