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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream Vue PACS; MX WEB SVR W/3 MXRAD LIC75K EX/YR

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  Class 2 Device Recall Carestream Vue PACS; MX WEB SVR W/3 MXRAD LIC75K EX/YR see related information
Date Initiated by Firm September 16, 2013
Date Posted November 13, 2013
Recall Status1 Terminated 3 on December 21, 2015
Recall Number Z-0248-2014
Recall Event ID 66306
510(K)Number K110919  
Product Classification System, image processing, radiological - Product Code LLZ
Product Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Code Information Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8274888
Recalling Firm/
Manufacturer		 Carestream Health Inc.
150 Verona St
Rochester NY 14608-1733
For Additional Information Contact
800-328-2910
Manufacturer Reason
for Recall		 Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
FDA Determined
Cause 2		 Software design
Action Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time. For questions regarding this recall call 1-800-328-2910.
Distribution Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.
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 = CARESTREAM HEALTH, INC.
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