Class 2 Device Recall Merge OrthoPACS

• Date Initiated by Firm: May 24, 2017
• Create Date: June 16, 2017
• Recall Status: Terminated on October 15, 2019
• Recall Number: Z-2601-2017
• Recall Event ID: 77271
• 510(K)Number: K022881 K082144 K092915
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Code Information: Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: MergeSupport@us.ibm.com; 877-741-5369
• Manufacturer Reason for Recall: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Merge Healtcare sent an Urgent Medical Device Recall letter dated May 19, 2017, via email on May 24, 2017. The letter notifies the customer of the issue, informs them to be aware of the workaround, and that a fix is available for the issue in Merge OrthoPACS 6.6.3.2 (or later). 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 15 calendar days after receipt of the recall letter using the enclosed form. 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 recalling firm will contact all unresponsive customers with a second customer letter, followed by a third customer letter. They may additionally contact customers that are unresponsive via telephone. For further questions, please call ( 877) 741-5369.
• Quantity in Commerce: 160 sites potentially have the affected versions
• Distribution: USA (nationwide) Distribution was made to medical facilities. 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; 510(K)s with Product Code = LLZ