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.
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 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, fitting the Moderate category for a precautionary software recall.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software. The recall involves specific client workstation versions, including 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8656456. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
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 ability to view certain diagnostic images on the affected workstations.
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 of the affected software should contact Carestream Health for further instructions on resolving the issue.
The recalled product
- Product
- Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS 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
- 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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