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.
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: 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, skeleta
- 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.
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