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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a High severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS client workstation software. The recall is due to a software problem that may prevent some images from multi-slice studies, such as CT and MR, from loading into the viewer application under very specific conditions.
The affected products are Vue PACS client versions 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 8978504. The distribution pattern includes 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.
The FDA has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the issue affects the display of medical images in hospital and related institutions.
The recalled product
- Product
- Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE 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 an
- 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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