Siemens x-ray display system support arm may lower unexpectedly
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
What this means for you
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 risk-of-harm product (structural mechanical failure in medical equipment) where no injuries have been reported, meeting the score 3 criterion per the rubric: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Luminos Agile Max x-ray imaging system (Model 10762472). The support arm may unintentionally lower during display positioning, creating a risk of injury to persons positioned beneath the ceiling or wall-mounted display.
Approximately 333 units have been distributed nationwide across the United States. Specific serial numbers are identified in the FDA recall notice.
The recalled product
- Product
- Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device
- Affected units
- 333
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)04056869009162(21) Serial Numbers
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- 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
- 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 · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28