Class 2 Device Recall Fusion Workstation

• Date Initiated by Firm: October 28, 2011
• Create Date: October 20, 2016
• Recall Status: Terminated 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/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: Merge Service and Support; 877-741-5369
• Manufacturer Reason for Recall: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
• FDA Determined Cause: 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.