Luminos Agile Diagnostic Imaging System Collision Risk Recall
Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.
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 3/5 (High).
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: This is a Class II medical device recall for a collision hazard that could result in serious injury to staff or patients. The hazard is theoretical with no reported injuries in the recall notice, placing it in the 'High' severity category—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Luminos Agile diagnostic imaging system (Model 10502200), a device used for radiographic and fluoroscopic studies. The recall initially involved 4 units, expanded to 93 units total, with nationwide distribution across the United States.
The recall is due to a potential collision hazard. When room configuration parameters are set to default values, the device may collide with the ceiling, walls, or nearby objects, potentially resulting in serious injury to staff or patients.
The recalled product
- Product
- Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · collision hazard
See all →- Moderate
- HighRicky Powersports Youth ATVs recalled for safety standard violations
CPSC · 2023-05-04
- HighKubota RTV-XG850 Utility Vehicles Recall for Steering Shaft Failure
CPSC · 2022-12-01
Similar recalls
- ModerateSiemens Luminos Agile Max Imaging System Software Recall
FDA (Devices) · 2015-06-03
- HighSiemens Medical Imaging Systems Recalled for Image Loss and Labeling Errors
FDA (Devices) · 2014-10-08
- HighSiemens Luminos Agile Max Recalled for Software Collision and Image Errors
FDA (Devices) · 2020-08-12
- HighSiemens Luminos Agile Max X-ray System Recalled for Collision Risk
FDA (Devices) · 2020-02-26
- HighSiemens Recalls Angiographic X-Ray Systems Due to Table Collision Risk
FDA (Devices) · 2013-04-17
- HighSiemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images
FDA (Devices) · 2020-02-26