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 under specific conditions.
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. The hazard involves a software defect that may prevent image loading, which is a functional issue rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
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 addresses a software problem that can prevent certain images from multi-slice studies, such as CT and MR scans, from loading into the viewer application.
This issue occurs under very specific conditions. The affected software is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities. The recall covers units distributed worldwide, including the United States, Canada, Japan, and Kuwait.
Hospitals and related institutions using the affected software should contact Carestream Health for further instructions on how to resolve the software defect.
The recalled product
- Product
- Carestream Vue PACS; UNLIMITED READING LIC ADD 10K 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…
- 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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