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.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software defect affecting image loading without reporting any specific 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 client workstation software. The recall involves specific versions of the software, including 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1384700.
The recall is due to a software problem that, under very specific conditions, may cause some images from multi-slice studies, such as CT and MR, to fail to load into the viewer application. This issue affects the display of 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 Carestream Vue PACS system should contact Carestream Health for further instructions regarding the software update or replacement.
The recalled product
- 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
- Manufacturer
- Carestream Health Inc.
- Category
- Medical Device — Software
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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