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.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The specific hazard is a software defect preventing image loading, which is a functional failure rather than a direct physical injury risk.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS client workstation software. The affected versions are 11.3.2.0, 11.3.2.4, and 11.4, with catalog number 1981042. The product is an image management system intended to archive, distribute, retrieve, and display images and data from hospital modalities.
The recall is due to a software problem where, under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application. This issue affects the ability to view certain medical images on the client workstation.
The affected products were distributed worldwide, including in 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. Users of the affected software versions should contact Carestream Health for further instructions on resolving the issue.
The recalled product
- Product
- Carestream Vue PACS; UPG MX-RAD SVR 15K 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…
- 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.
See all 50 products in this recall →Related recalls
Same manufacturer · Carestream Health Inc.
See all →- HighDRX Revolution Mobile X-Ray System Electrical Component Failure Recall
FDA (Devices) · 2023-12-13
- HighDRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly
FDA (Devices) · 2023-11-15
- HighX-ray System Overhead Crane May Continue Moving Unexpectedly
FDA (Devices) · 2023-03-08
- HighCarestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement
FDA (Devices) · 2020-01-22
- ModerateCarestream OnSight 3D Extremity System Recalled for Software Data Error
FDA (Devices) · 2019-05-01
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateCarestream Image Suite V3 Recalled for Incorrect Image Annotation
FDA (Devices) · 2016-05-11
- ModerateCarestream DirectView CR Software Recalled for Reduced Mammographic Image Quality
FDA (Devices) · 2014-12-24
- HighMerge PACS software recall due to unviewed image display defect
FDA (Devices) · 2016-11-23
- HighPhilips Vue PACS Diagnostic Viewer Software Recall for Calculation Errors
FDA (Devices) · 2024-11-27
- HighMerge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up
FDA (Devices) · 2016-10-26
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23