Siemens recalls LUMIN:OS Lotus Max (VF11) fluoroscopy systems due to rare risk of incorrect air kerma display during exams. No impact on workflow or diagnosis. Affected models: 11574100.
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 its LUMINOS Lotus Max (VF11) fluoroscopy systems because they might show incorrect air kerma readings during certain exams. This error is rare and doesn't affect patient care or workflow, but could theoretically cause confusion in measurements.
The fluoroscopy system might display incorrect air kerma readings during rare circumstances in fluoroscopy exams. This error only happens in systems with a second overhead X-ray tube and follows IEC 60601-2-43 standards. The error doesn't affect patient care or workflow.
Healthcare facilities using Siemens LUMINOS Lotus Max (VF11) fluoroscopy systems with model 11574100 are affected. Medical staff performing fluoroscopy exams are most at risk due to potential measurement confusion.
Check if your system has the model number 11574100. The product is sold under the LUMINOS Lotus Max (VF11) name. This recall applies to specific fluoroscopy systems used in medical imaging.
Verify your system's model number is 11574100 to confirm if it's affected.
No, the error does not impact patient care or workflow. The recall states there is no impact on diagnosis or patient safety.
The error is described as 'unlikely' and only occurs under specific circumstances in fluoroscopy systems with a second overhead X-ray tube.
No, the recall does not require stopping use. The error is rare and does not affect workflow or diagnosis.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1481-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1481-2023 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.
