Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a software defect may prevent some CT and MR images from loading.
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a software defect that may prevent image loading, which is a functional issue rather than a direct physical injury risk, aligning with a Moderate severity rating.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS image management system. The recall affects specific software versions, including 11.3.2.0, 11.3.2.4, and 11.4, which are used in hospital and related institutions to archive, distribute, retrieve, and display medical images.
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 could impact the ability of healthcare providers to view certain diagnostic images.
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 instructions on how to resolve the software issue.
The recalled product
- Product
- Carestream Vue PACS; UNLIMITED READING LIC ADD 25K 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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