Carestream Vue PACS Software Recall for Image Loading Defect
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.
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 under specific conditions without reporting any injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Carestream Health, Inc. has issued a recall for the Carestream Vue PACS image management system. The recall affects specific software versions, including 11.3.2.0, 11.3.2.4, and 11.4, which are used to archive, distribute, retrieve, and display medical images in hospital and related institutions.
The recall was issued because a software problem may prevent some images from multi-slice studies, such as CT and MR scans, from loading into the viewer application under very specific conditions. This defect could impact the ability to view certain diagnostic images.
The affected products were distributed worldwide, including in the United States and internationally to Canada, Japan, and Kuwait. Users of the affected software versions should contact Carestream Health for further instructions on how to resolve the issue.
The recalled product
- Product
- Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/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, retrie
- 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 →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25