Siemens recalls Luminos Agile X-ray systems with software VC10 due to potential ceiling/wall collisions causing serious injury. Affected units have specific serial numbers. Contact for remedy.
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 diagnostic imaging systems with software VC10 because default room configuration settings could cause the machine to collide with walls or ceilings, risking serious injury to staff or patients. This affects specific serial numbers 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. This collision could result in serious injury to staff or patients during medical procedures.
Healthcare facilities using the Luminos Agile system with software VC10 are most at risk. Staff and patients in rooms where the machine is installed could be injured if the system collides with walls or ceilings.
Check the serial number on the system. Affected units have specific serial numbers listed in the recall notice, including ranges from 60011 to 60473. The system was sold with software version VC10 for radiographic and fluoroscopic studies.
Identify the serial number on your Luminos Agile system to see if it matches the affected range (60011-60473).
Reach out to Siemens Medical Solutions USA, Inc. for instructions on how to address the issue.
The system's room configuration parameters are set to default values that could cause collisions with walls, ceilings, or objects, risking serious injury to staff or patients.
Check the serial number against the affected range (60011-60473). Contact Siemens Medical Solutions USA, Inc. for instructions.
Yes, if the system collides with walls, ceilings, or objects during use, it could cause serious injury to staff or patients.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1164-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1164-2023 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.
