Carestream Vue PACS Software Recall for Image Loading Defect
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 temporary or medically reversible adverse health consequence or a remote probability of serious adverse health consequences. The specific defect involves software failure to load images, which is a functional issue rather than a direct physical hazard like fire or shock, placing it in the moderate range for a medical device software recall without reported injuries.
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 8485021. This product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
The recall was issued 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. The agency classification for this recall is Class II.
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 should contact Carestream Health for further instructions regarding this software defect.
The recalled product
- Product
- Carestream Vue PACS; UPG MX-O 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, retrieve
- 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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