Class 2 Device Recall Merge Cardio Software

• Date Initiated by Firm: April 04, 2016
• Create Date: March 19, 2017
• Recall Status: Terminated on July 26, 2019
• Recall Number: Z-1486-2017
• Recall Event ID: 76431
• 510(K)Number: K051649
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge Cardio software.
• 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, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.
• 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: Cardio study list does not show STAT studies without refreshing.
• FDA Determined Cause: Software design
• Action: The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated 7/11/2016.
• Quantity in Commerce: 217 sites potentially have the affected versions
• Distribution: Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/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