Diagnostic imaging system recalled for collision risk from default settings
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking 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: The recall involves a risk-of-harm medical device where collision with facility infrastructure could cause serious injury to staff or patients. No injuries, illnesses, or deaths have been reported, and the hazard is potential rather than actual, placing this at the high-risk threshold for FDA Class II devices per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. has recalled 506 units of the Luminos Agile Max diagnostic imaging system with software versions VE10 and VF11, used for radiographic and fluoroscopic imaging studies. All recalled units were distributed nationwide within the United States.
The recall addresses a configuration hazard. The system's room configuration parameters default to settings that allow the imaging equipment to collide with the ceiling, walls, or objects in the examination room. These collisions could result in serious injury to staff or patients.
Healthcare facilities using Luminos Agile Max systems should verify their equipment's serial number against the recall list to determine if they are affected.
The recalled product
- Product
- Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
- 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.
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