Class 2 Device Recall Merge PACS

• Date Initiated by Firm: May 08, 2017
• Create Date: June 15, 2017
• Recall Status: Terminated on August 08, 2019
• Recall Number: Z-2591-2017
• Recall Event ID: 77249
• 510(K)Number: K082144
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
• Code Information: Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: Merge Service and Support; 877-741-6369
• Manufacturer Reason for Recall: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Merge sent an Urgent Medical Device Recall letter dated May 5, 2017, to all affected customers. Customers were instructed to be aware of the following workaround: Do not have the simple close study red x icon available in the reading physicians toolbars. This will force them to set status on close which also presents the warning Not all images have been reviewed, do you want to set status anyway and close study or continue reviewing unviewed images? YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED By replying to this notification, you will be taking the necessary steps to ensure that the issue listed in this document will be resolved. Please reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-6369.
• Quantity in Commerce: 47 sites have the potentially affected 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