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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 January 30, 2016
Create Date July 29, 2016
Recall Status1 Terminated 3 on April 08, 2019
Recall Number Z-2301-2016
Recall Event ID 74648
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.

Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Code Information Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.
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		 Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued Urgent: Medical Device Recall letters dated 1/27/2016 and 5/26/2016. The letter informed the customer of the affected product, the nature of the issue, the potential harm involved, and actions to be taken. The firm released a fix for the issue; and, customers were asked to complete and return the enclosed form by June 17, 2016. Questions can be directed to recall@merge.com.
Quantity in Commerce 109 sites have the affected versions
Distribution Worldwide Distribution -- USA, New Zealand, and United Kingdom.
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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