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 application.
What this means for you
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 preventing image loading, which is a functional failure rather than a direct physical injury risk.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software, specifically the Virtual PWR Reading Basic SW, Workgroup. The affected software versions are 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1308519.
The recall was issued because, under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. This issue affects the Carestream Client Workstation.
The product was distributed worldwide, including in the United States (AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA, WA, and WI) 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, re
- 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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