Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.
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, and the hazard involves a software defect that may prevent image loading. No injuries or illnesses have been reported, and the issue is limited to specific conditions, fitting the criteria for a moderate severity recall.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS client workstation software. The recall affects specific versions of the software, including 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8859811. 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 a software problem may cause some images from multi-slice studies, such as CT and MR, to fail to load into the viewer application under very specific conditions. The affected units were distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait.
Hospitals and related institutions using the affected software versions should contact Carestream Health for further instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
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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