Diagnostic imaging system recalled for collision risk from default settings
Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in 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: This FDA Class II recall describes a risk-of-harm product with no reported injuries or deaths. The hazard—equipment collision risk from default configuration settings—meets the criteria for High severity as a risk-of-harm situation without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Luminos dRF Max diagnostic imaging system (Model 10762471) due to a risk of collision with room structures and objects. The system's room configuration parameters are set to default values that do not account for the specific physical space of the installation, creating a potential collision hazard with the ceiling, walls, or nearby objects.
This recall affects units distributed nationwide across the United States. Two units were initially identified, and the recall was expanded on February 24, 2023, to include a total of 53 affected units. Specific serial numbers are identified in the recall notice.
If your facility operates one of these systems, immediately contact Siemens Medical Solutions USA, Inc. to verify your serial number and obtain instructions for correcting the room configuration settings. Do not operate the system until the configuration parameters have been properly adjusted for your specific installation environment.
The recalled product
- Product
- Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
- 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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