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
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 describes a software defect that may prevent image loading without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS software, specifically the Virtual PWR Reading Basic SW 8 Pack. The affected software versions are 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1405794.
The recall was initiated because a software problem may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
The affected units were distributed worldwide, including in the United States 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; Virtual PWR Reading Basic SW 8 Pack 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, retrie
- 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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