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.
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, but the source text describes a software defect that prevents image loading without reporting any injuries, illnesses, or deaths. This aligns with the criteria for a moderate severity score involving low-risk technical issues or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software. The recall involves specific client workstation versions where a software problem prevents certain images from loading into the viewer application.
The issue occurs under very specific conditions when using multi-slice studies, such as CT and MR images. The affected software versions are 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1467067. The 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 internationally to Canada, Japan, and Kuwait. Users should contact Carestream Health for further instructions regarding the software update or replacement.
The recalled product
- Product
- Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup 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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