Siemens recalls Luminos Agile Max (VE10, VF10, VF1:1) fluoroscopy systems that may display incorrect air kerma rates during exams. No impact on diagnosis or workflow, but potential for rare errors in specific systems.
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
Siemens is recalling certain Luminos Agile Max fluoroscopy systems that could show incorrect air kerma rates during exams. This error is rare and only affects specific systems with overhead X-ray tubes, but it may cause confusion in patient measurements.
The fluoroscopy system may display incorrect air kerma rates during exams under very rare circumstances. This error occurs only in systems with an overhead X-ray tube and is not expected to affect diagnosis or workflow.
Medical facilities using Siemens Luminos Agile Max systems with model numbers VE10, VF10, or VF11 are likely affected. Patients undergoing fluoroscopy exams with these systems are at minimal risk.
Check for model numbers VE10, VF10, or VF11 on the Luminos Agile Max system. The recall applies to systems sold with the model number 10762472.
Identify the model number on your Luminos Agile Max system to confirm if it is VE10, VF10, or VF11.
No, the error does not impact patient safety or diagnosis. It is a rare display issue that does not affect workflow.
The error is extremely rare and only occurs in specific systems with overhead X-ray tubes during fluoroscopy exams.
The recall does not mention a fix. Siemens Healthineers became aware of the issue at one customer site but no remedy is provided.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1479-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1479-2023 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.
