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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 22, 2017
Recall Status1 Terminated 3 on June 28, 2019
Recall Number Z-2620-2017
Recall Event ID 77265
510(K)Number PACS-K082144  OrthoCase-K022881  iConnect-K092915  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge OrthoPACS software.
Code Information Versions 6.6, 6.6.1, and 6.6.2
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
Manufacturer Reason
for Recall
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
FDA Determined
Cause 2
Software design
Action The recalling firm issued a letter dated 5/19/2017 via email on 5/24/2017 or via certified mail if they did not have an email address for the customer.
Quantity in Commerce 98 sites potentially have the affected versions
Distribution Distribution was made nationwide 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.