LUMINOS Lotus Max fluoroscopic system recalled for sporadic measurement errors
LUMINOS Lotus Max fluoroscopic systems may sporadically display incorrect radiation dose measurements. The error only occurs with secondary X-ray tubes and does not affect diagnosis or workflow.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses and explicit statement of no clinical impact. The sporadic measurement error affects only systems with secondary X-ray tubes and does not affect diagnosis or workflow.
Plain-English summary
The FDA is recalling the LUMINOS Lotus Max (model 11574100) fluoroscopic imaging system manufactured by Siemens Medical Solutions USA, Inc. Under certain unlikely circumstances, the system can sporadically display an incorrect air kerma or air kerma rate at the patient reference point as defined by IEC 60601-2-43 standard.
The error occurs only in fluoroscopic systems equipped with a secondary (overhead) X-ray tube. Approximately 704 units are affected in the United States, with 1,945 units distributed worldwide. According to the manufacturer and FDA, the incorrect display does not impact clinical workflow or diagnosis.
Users with affected systems should be aware of this potential anomaly. Healthcare facilities should contact Siemens Medical Solutions USA, Inc for information on any necessary corrections or monitoring procedures.
The recalled product
- Product
- LUMINOS Lotus Max (VF11)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- dose-measurement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: 11574100
Distribution
Distributed nationwide across the United States.
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