Siemens Luminos Agile Max Imaging System Software Recall
Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.
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. The hazard involves data loss and operational errors (image deletion, connection issues) rather than direct physical injury, fitting the criteria for a moderate severity recall involving significant functional defects without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 133 units of the Luminos Agile Max universal imaging system. The recall is due to a software defect in version VE10E that can cause acquired images and studies to be deleted, requiring acquisitions to be repeated. Additionally, the system experiences sporadic connection issues with portable detectors (MAX wi-D, MAX mini) during image recovery.
The defect may also occur when pressing the undo button on the RAD subtask card or the previous series button on the Image subtask card during image readout, or during automatic or manual RIS updates. The affected devices were distributed nationwide.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue and ensure data integrity for future imaging studies.
The recalled product
- Product
- SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is a
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 133
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, 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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