Carestream Vue PACS Software Recall for Image Loading Defect
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a software defect causing image loading failures, which is a functional issue rather than a direct physical injury or life-threatening condition.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software, specifically the Virtual Access Pluse SW, StandAlone. The recall involves specific client workstation versions (11.3.2.0, 11.3.2.4, and 11.4) with catalog number 1337195.
The recall was initiated due to a software problem that, under very specific conditions, may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application. This defect affects the intended use of the image management system to archive, distribute, retrieve, and display images from hospital modalities.
The affected products were distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. Users of the affected software versions should contact Carestream Health for further instructions on resolving the issue.
The recalled product
- Product
- Carestream Vue PACS; Virtual Access Pluse SW, StandAlone 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
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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