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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS Software V6.0.2.0 MR2

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  Class 2 Device Recall Merge PACS Software V6.0.2.0 MR2 see related information
Date Initiated by Firm January 30, 2016
Create Date August 10, 2016
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-2379-2016
Recall Event ID 74773
510(K)Number K082144  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Code Information Versions: V6.0.2.0 MR2 and earlier
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		 The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users. A second letter was issued to nonresponders dated 5/25/2016
Quantity in Commerce 93 sites have the affected version
Distribution The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no 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.
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