Class 2 Device Recall Merge RadSuite software

• Date Initiated by Firm: November 17, 2015
• Date Posted: February 09, 2017
• Recall Status: Terminated on February 10, 2017
• Recall Number: Z-1180-2017
• Recall Event ID: 76258
• 510(K)Number: K053281
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Code Information: Version V8.30.7.8
• 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: The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
• FDA Determined Cause: Software design
• Action: Merge sent an Urgent Medical Device Recall letter dated March 28, 2016 to all affected customers. The letter notifies the customer of the issue and informs them an upgrade is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. A second letter dated July 11, 2016, was issued asking for a response by August 2, 2016, even though all upgrades were made because the effectiveness checks were not yet completed. The letter and response form contained the same information as the first letter. The recalling firm reported emails were tracked for delivery confirmation and the letters were tracked for delivery by USPS certified services. For further questions, please call 877-744-5369.
• Quantity in Commerce: 8 sites have the potentially affected version
• Distribution: US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
• 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 and Original Applicant = EMAGEON INC.