Class 2 Device Recall Merge Cardio

• Date Initiated by Firm: April 04, 2016
• Date Posted: March 03, 2017
• Recall Status: Terminated on July 26, 2019
• Recall Number: Z-1403-2017
• Recall Event ID: 76590
• 510(K)Number: K051649
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
• 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, and 10.0.
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: Merge Service & Support; 877-741-5369
• Manufacturer Reason for Recall: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
• FDA Determined Cause: Software design
• Action: Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
• Quantity in Commerce: 110 sites potentially have the affected versions
• Distribution: Distribution was made to medical facilities nationwide. There was no foreign/military/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