Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED 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.
- Company
- Carestream Health, Inc.
- Recall Initiated
- September 16, 2013
- Posted
- November 13, 2013
- Terminated
- December 21, 2015
- Recall Number
- Z-0259-2014
- Firm Location
- Rochester, NY
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.
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.
Lot / Code Info
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8441602
Root Cause
Software design
Action Taken
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.