Class 2 Device Recall Merge Cardio software

• Date Initiated by Firm: October 01, 2015
• Create Date: December 09, 2016
• Recall Status: Terminated on March 23, 2018
• Recall Number: Z-0730-2017
• Recall Event ID: 75714
• 510(K)Number: K051649
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data
• Code Information: Versions V10.1 and 10.1.1
• 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: Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
• FDA Determined Cause: Software design
• Action: MERGE sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. Non-responders were issued a second letter dated July 11, 2016, The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to reply using the enclosed form and the return addressed envelope and also to ensure that all users of the product were provided with the notification. If product was further distributed, customer were asked to identify their customers and notify them at once of the product recall. Customers with questions were advised to email recall@merge.com. For questions regarding this recall call 877-741-5369.
• Quantity in Commerce: 116 sites potentially have the effected versions
• Distribution: 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