Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.
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, but the source text describes a software defect that prevents image loading without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS client software, specifically versions 11.3.2.0, 11.3.2.4, and 11.4. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
The recall was initiated due to a software problem that, under very specific conditions, may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application. The affected units were distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait.
Healthcare institutions using the affected software versions should contact Carestream Health for further instructions on resolving the issue. No specific instructions for end-users are provided in the source text, as the product is intended for institutional use.
The recalled product
- Product
- Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR 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
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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