Siemens Luminos Agile Max X-ray System Recalled for Collision Risk
Siemens is recalling 475 Luminos Agile Max X-ray systems because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.
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: The recall involves a risk-of-harm product (collision with persons) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 475 units of the Luminos Agile Max, Model No. 10762472, an X-ray system used to visualize anatomical structures. The recall is due to a defect where the bypass key can be used to override the built-in collision control. This override creates a risk of collision with obstacles or persons when the operator uses the function.
The affected devices were distributed nationwide in the United States. Siemens became aware of the issue regarding the incorrect use of the bypass key. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Healthcare facilities should check their serial numbers against the list provided by the FDA to determine if their device is affected. The source text does not provide specific consumer instructions beyond the recall notice.
The recalled product
- Product
- Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 475
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 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 injury
See all →- HighSiemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory
FDA (Devices) · 2019-05-01
- HighSynTec S3B Track Mounted Seats Recalled for Rear-End Collision Risk
NHTSA · 2015-11-09
- HighSiemens Linear Accelerators Recalled for Potential Patient Collision Risk
FDA (Devices) · 2014-08-20
Similar recalls
- HighSiemens Luminos Agile Max Recalled for Software Collision and Image Errors
FDA (Devices) · 2020-08-12
- HighSiemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images
FDA (Devices) · 2020-02-26
- HighSiemens Luminos dRF Max Recalled for Software Collision and Image Errors
FDA (Devices) · 2020-08-12
- HighSiemens x-ray display system support arm may lower unexpectedly
FDA (Devices) · 2024-08-14
- 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