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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS

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  Class 2 Device Recall Merge PACS see related information
Date Initiated by Firm February 05, 2016
Create Date August 08, 2016
Recall Status1 Terminated 3 on October 25, 2016
Recall Number Z-2363-2016
Recall Event ID 74776
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, Inc., Hartland, WI.

Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Code Information Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall		 When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
FDA Determined
Cause 2		 Software design
Action The recalling firm's customer support notified customers via phone call beginning 2/5/2016 to inform them of the issue. Customers were informed that a software fix that corrects the issue was available. Customers were asked not to use the measurements on mammo images until upgraded. If customers want an upgrade, then someone would contact them to schedule the upgrade.
Quantity in Commerce 49 sites potentially have the affected versions
Distribution Worldwide Distribution -- USA and Australia.
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.
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