Carestream Vue PACS Software Recall for Image Loading Defects
Carestream Health is recalling Vue PACS software due to a defect that may prevent certain 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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software, specifically affecting client versions 11.3.2.0, 11.3.2.4, and 11.4. The recall is due to a software problem that may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions.
The affected software is distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities and information systems.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as FDA Class II.
The recalled product
- Product
- Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR 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
- 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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