Carestream Vue PACS Software Recall for Image Loading Defects
Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR 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 source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving a software defect without reported harm.
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 is due to a software problem that can prevent certain images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions.
The affected product 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 and international locations such as Canada, Japan, and Kuwait.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Carestream Vue PACS; MX WEB SW/5 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…
- 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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