Fluoroscopic imaging system may display incorrect radiation dose readings
Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.
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: This is a Class II recall with no reported illnesses, injuries, or deaths. The source explicitly states the error has no impact on clinical workflow or diagnosis. Per the severity rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3. The minimal practical impact—unlikely circumstances, identified at only one site, and no clinical effect—supports assignment of Moderate (2) rather than the maximum possible High (3).
Plain-English summary
Siemens Medical Solutions USA, Inc. has recalled certain Luminos Agile Max fluoroscopic imaging systems (models VE10, VF10, VF11) due to a potential software issue. Under certain unlikely circumstances, the system may display incorrect air kerma (radiation dose) values or rates at the patient reference point according to IEC 60601-2-43 standards.
The company identified this issue during clinical operation at one customer site. Siemens states that the error does not affect clinical workflow or diagnostic accuracy. The issue occurs only in systems equipped with a second (overhead) X-ray tube.
Approximately 704 units are affected in the United States, with 1,945 units affected worldwide. Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for guidance on software updates or other remediation measures.
The recalled product
- Product
- Luminos Agile Max (VE10, VF10, VF11)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- radiation-dose-measurement-error
- incorrect-dose-display
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: 10762472
Distribution
Distributed nationwide across the United States.
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