Diagnostic Imaging System Recalled for Potential Ceiling and Wall Collision Risk
Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.
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: FDA classified this as a Class II recall for a medical device with potential for serious injury. No hospitalizations or injuries are explicitly reported in the source, but the collision hazard poses significant risk of harm to patients and staff. Per the rubric, risk-of-harm products without reported injuries score as 'High.'
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Luminos dRF with software VD10, a diagnostic imaging system used for radiographic and fluoroscopic studies. The system is at risk of collision with the ceiling, wall, or other objects in the examination room when room configuration parameters are set to default values.
The affected units are distributed nationwide in the United States. The recall initially involved one unit and was expanded to include 25 additional units identified by specific serial numbers.
Collisions with ceilings, walls, or objects could result in serious injury to patients and staff. Healthcare facilities should verify they are not using an affected unit and contact the manufacturer for proper configuration guidance.
The recalled product
- Product
- Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
- 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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