Siemens recalls Luminos Agile Max diagnostic imaging systems with software VE10 & VF11 due to potential collision risks with walls or ceilings that could cause serious injury to staff or patients.
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Siemens is recalling Luminos Agile Max diagnostic imaging systems with software VE10 and VF11 because the room configuration settings may cause the machine to collide with walls or ceilings, potentially injuring staff or patients. This recall affects specific serial numbers and models sold between 2023 and 2024.
The system's room configuration parameters are set to default values that may cause it to collide with walls, ceilings, or objects during operation. This collision could result in serious injury to staff or patients if the machine moves unexpectedly.
Healthcare facilities using the Luminos Agile Max imaging system with software VE10 or VF11 are most at risk. Staff and patients in rooms where the system is installed could be injured if the machine collides with walls or ceilings.
Check for the model number 10762472 and serial numbers listed in the expanded recall (2023-2024). The system uses software versions VE10 or VF11 for radiographic and fluoroscopic studies.
Verify if your system has software versions VE10 or VF11 by checking the software version in the system's settings.
Reach out to Siemens Medical Solutions USA, Inc. for assistance with the recall and to confirm if your system is affected.
This recall affects Luminos Agile Max systems with software VE10 or VF11 and specific serial numbers listed in the expanded recall (2023-2024). Check your serial number against the list provided by Siemens.
Look for the model number 10762472 and serial numbers in the expanded recall list (2023-2024). Systems with software versions VE10 or VF11 are affected.
Contact Siemens Medical Solutions USA, Inc. to confirm if your system is affected and to get guidance on next steps.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1165-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1165-2023 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
