Carestream Vue PACS Software Recall for Image Loading Defect
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, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported. The hazard is a software defect causing image loading failures, 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 image management system. The recall involves specific client workstation software versions, including 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8485021.
The recall was initiated 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 system is intended to archive, distribute, retrieve, and display images and data from hospital modalities and information systems.
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 issue.
The recalled product
- Product
- Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED 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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