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 into 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 corresponds to a moderate severity score. The hazard involves a software defect that may prevent image loading, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software. The recall involves specific client workstation versions, including 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8101768.
The recall was issued because a software problem may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions. This issue affects the image management system's ability to display certain data.
The affected products were 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 WEB SVR W/3 MX-O LIC< 7.5K EXAMS 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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