RecallRadar

FDA Device recall Z-0254-2014

Carestream Vue PACS

On 2013-11-20 the FDA classified a Class II recall of Carestream Vue PACS by Carestream Health, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0254-2014
ClassificationClass II
Statusterminated
Initiated2013-09-16
Published2013-11-20
Last updated2026-09-13 11:53 UTC
CompanyCarestream Health
DistributionAR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA, WA, WI

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, retrieve and display images and data from all hospital modalities and information systems.

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.

Identifiers

code_infoModel: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1387042

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Other recalls by Carestream Health

All Carestream Health recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0254-2014%22

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