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U.S. Department of Health and Human Services

Class 2 Device Recall Merge OrthoPACS

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  Class 2 Device Recall Merge OrthoPACS see related information
Date Initiated by Firm May 24, 2017
Create Date June 16, 2017
Recall Status1 Terminated 3 on October 15, 2019
Recall Number Z-2601-2017
Recall Event ID 77271
510(K)Number K082144  K022881  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,, and
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact MergeSupport@us.ibm.com
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 2
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 (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 and Original Applicant = AMICAS, INC.
510(K)s with Product Code = LLZ and Original Applicant = CEDARA SOFTWARE CORP.