Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software due to a defect that may prevent some CT and MR images from loading in the viewer.
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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Carestream Health, Inc. is recalling the Carestream Vue PACS client software. The affected versions are 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8215956. This product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
The recall was issued because of a software problem that may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application. This issue occurs under very specific conditions. The agency has classified this recall as Class II.
The affected software was distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. Users of the Carestream Vue PACS client workstation should contact Carestream Health for further instructions regarding the software update or replacement.
The recalled product
- Product
- Carestream Vue PACS; UPG MX-O SVR 7.5K 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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