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.
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 injuries or illnesses, fitting the criteria for a moderate severity recall involving a software defect without reported harm.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS Client Workstation software. The recall addresses a software problem that prevents certain images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions.
The affected products include Vue PACS client versions 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1013226. The distribution pattern for these products is worldwide, including specific US states and international locations such as Canada, Japan, and Kuwait.
This recall is classified as Class II by the FDA. The source text does not report any injuries, illnesses, or deaths associated with this software defect. Users should contact Carestream Health for further instructions regarding the software update or replacement.
The recalled product
- 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
- 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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