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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical imaging software) where injury has not yet been reported, fitting the 'High' severity criteria.
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 8711459. This 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. The agency has classified this as a Class II recall.
The affected software was 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 the software issue.
The recalled product
- Product
- Carestream Vue PACS; UPG MX-O SVR 25K 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
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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