Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a software defect that prevents image loading under specific conditions, which is a functional issue rather than a direct physical injury risk.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS client workstation software. The recall affects specific versions of the software used in hospital and related institutions to archive, distribute, retrieve, and display medical images.
The recall was issued because, under very specific conditions, some images from multi-slice studies, such as CT and MR, may not load into the viewer application due to a software problem. This issue is limited to the loading of specific image types in the viewer and does not indicate a hardware failure or data loss in the archive.
The affected products were distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. Users of the affected software versions should contact Carestream Health for further instructions on how to resolve the issue.
The recalled product
- Product
- Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K 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…
- 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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