Class 2 Device Recall Merge Cardio

• Date Initiated by Firm: January 30, 2016
• Create Date: September 21, 2016
• Recall Status: Terminated on December 15, 2017
• Recall Number: Z-2865-2016
• Recall Event ID: 75034
• 510(K)Number: K051649
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
• Code Information: Version 10.1
• 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: Patient information in the header is only found on the first page of the report and not on the subsequent pages.
• FDA Determined Cause: Software design
• Action: Merge sent an Urgent Medical Device Recall letter dated January 28, 2016 to affected customers via e-mail or via certified mail if they did not have an e-mail address. The letter identified the affected product, problem and actions to be taken. For questions call Merge Customer Service at (877)741-5369 or support@merge.com.
• Quantity in Commerce: 42 sites potentially have the affected version
• Distribution: US Nationwide 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