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Recall Observatory FDA recall evidence

Device product

Carestream Vue PACS; UPG MX-O SVR 25K 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.

Z-0244-2014

September 16, 2013

Class II

Product summary

Firm
Carestream Health Inc.
Event
Event 66306
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0244-2014

Official wording

Reason: 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.

Code information: Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software problem