FDA (Devices) recall action 66306

Carestream Health Inc. recalled 50 products on 2013-11-20

The FDA (Devices) publishes a recall like this one as 50 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 50 pages.

Products: 50
Announced: 2013-11-20
Critical: 0
Units: —

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–25 of 50

ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer.
Product
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual Access Software, StandAlone 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, retr
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defects
Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual Enterprise SW StandAlone 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, retriev
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.
Product
Carestream Vue PACS; Unlimited Reading LIC<15K 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 a
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.
Product
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW 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
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer.
Product
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.
Product
Carestream Vue PACS; UNLIMITED READING LIC < 25K 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
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone 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, retr
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UPG MX-RAD SVR 15K 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, retriev
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer.
Product
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone 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, re
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.
Product
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT 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, retri
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defects
Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC 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, retriev
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UPG MX-RAD 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, retriev
Category
Distribution
26 states
HighFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
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
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UNLIMITED READING LIC < 50K 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
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer.
Product
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup 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, r
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual Reading Basic SW StandAlone 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, retr
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup 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, re
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer.
Product
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING 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
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.
Product
Carestream Vue PACS; Virtual Access Plus SW, Workgroup 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, retrie
Category
Distribution
26 states
ModerateFDA (Devices)··2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UPG MX-O SVR 15K 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
Category
Distribution
26 states