Carestream Vue PACS Software Recall for Image Loading Defects
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load 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, but the source text does not report any hospitalizations, injuries, or deaths, and the defect is a software issue affecting image loading rather than a direct physical hazard.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS client software, specifically versions 11.3.2.0, 11.3.2.4, and 11.4. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities. The recall is due to a software problem that prevents some images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions.
The affected software was distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. The recall is classified as Class II by the FDA. The source text does not report any specific illnesses, injuries, or deaths associated with this software defect.
Healthcare institutions using the affected software versions should contact Carestream Health for instructions on how to resolve the issue. The recall is limited to the specific software versions and catalog number 1849592 listed in the agency notice.
The recalled product
- Product
- Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC 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, retriev
- 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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