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.
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 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
- Hazard
- collision-hazard
- injury-risk
Distribution
Distributed nationwide across the United States.
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