Class 2 Device Recall Merge OfficePACS3.xDat

• Date Initiated by Firm: January 31, 2016
• Date Posted: July 11, 2016
• Recall Status: Terminated on January 26, 2017
• Recall Number: Z-2159-2016
• Recall Event ID: 74510
• 510(K)Number: K033825
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
• Code Information: Version 3.4
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: 262-367-0700
• Manufacturer Reason for Recall: Potential data loss occurs as a result of product archiving not working properly.
• FDA Determined Cause: Software design
• Action: The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.
• Quantity in Commerce: 49 sites have the affected software
• Distribution: Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign 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