Siemens recalls Luminos dRF Max models VE10, VF10, VF11 for potential incorrect air ker: a rate display during fluoroscopy, which does not affect patient diagnosis but could cause confusion in imaging settings.
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 is recalling Luminos dRF Max models VE10, VF10, and VF11 due to a rare possibility of incorrect air kerma rate displays during fluoroscopy. This error does not affect patient diagnosis but could lead to confusion in imaging settings.
The fluoroscopy system might display an incorrect air kerma rate during certain rare circumstances, which could confuse imaging settings. This error occurs only in systems with a second overhead X-ray tube and is unrelated to patient safety or diagnosis.
Healthcare professionals using Siemens Luminos dRF Max systems for fluoroscopy procedures may be affected. Patients are not at risk as the error does not impact diagnosis.
Check for Luminos dRF Max models VE10, VF10, or VF11 with serial number 10762471. The product was sold by Siemens Medical Solutions USA, Inc.
Identify if your system is a Luminos dRF Max model VE10, VF10, or VF11 with serial number 10762471.
No, the error does not impact patient diagnosis or safety.
The recall states there is no impact on patient diagnosis, so patients are not at risk.
Check for Luminos dRF Max models VE10, VF10, or VF11 with serial number 10762471.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1480-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1480-2023 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.