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 hazard involves a software defect that prevents image loading without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS Virtual Access Software, Workgroup. The recall involves specific client versions of the software used in image management systems for hospital and related institutions.
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. This defect affects the ability to view certain medical images within the system.
The affected software was distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. Users of the affected software versions should contact Carestream Health for further instructions on resolving the issue.
The recalled product
- Product
- Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, 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, retri
- Manufacturer
- Carestream Health Inc.
- Category
- Medical Device — Software
- Hazard
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.
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