The Recall Desk
ModerateFDA (Devices)·Z-0258-2014·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software. The affected product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities and information systems.

The recall was issued because, 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 affected units include Vue PACS client versions 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8296642.

The product was distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. The source text does not specify the number of affected units or report any illnesses or injuries.

The recalled product

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

Distribution

Part of a larger recall action

This product is one of 50 recalled by Carestream Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 50 products in this recall →