Class 2 Device Recall Merge PACS

• Date Initiated by Firm: May 08, 2017
• Create Date: June 15, 2017
• Recall Status: Terminated on August 05, 2019
• Recall Number: Z-2590-2017
• Recall Event ID: 77248
• 510(K)Number: K082144
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
• 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; 877-741-5369
• Manufacturer Reason for Recall: Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Merge Healthcare sent an Urgent Medical Device Recall letter dated May 5, 2017. The letter explains the issue and informs the customer to be aware of the workaround. The customer is also notified a software fix for the issue was released in Merge PACS 7.1.1 (or later). The customer is requested to ensure all users of the product are provided with the notification and if it has been further distributed, to notify downstream customers at once. The letter informs the customer a response is required 15 calendar days after receipt of the recall letter. The enclosed response asks, in part, if the customer is interested in accepting the fix and if not, to state the reason why. The recalling firm will contact all unresponsive customers a second and third time. Methods for contacting the customer may be by phone or email. For further questions, please call (877) 741-5369.
• Quantity in Commerce: 47 sites potentially have the affected versions
• Distribution: USA (nationwide) Distribution .There was no foreign/government/military 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