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, or where the probability of serious adverse health consequences is remote. 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 client workstation software. The affected versions are 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1981042. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
The recall is due to a software problem where, under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application. This issue affects the ability to view certain medical images on the client workstation.
The affected products were distributed worldwide, including in the United States (specifically 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 of the affected software versions should contact Carestream Health for further instructions on resolving the issue.
The recalled product
- Product
- Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED 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, retriev
- 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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