Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements
Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 FDA Class II recall involves a measurement display error in medical imaging equipment with no reported illnesses or injuries. The manufacturer explicitly states there is no impact on clinical diagnosis or workflow.
Plain-English summary
Siemens Medical Solutions is recalling approximately 704 Luminos dRF Max fluoroscopic imaging systems (models VE10, VF10, VF11) in the United States due to a potential measurement display error. Under certain unlikely operating circumstances during fluoroscopic examination, affected systems may sporadically display an incorrect air kerma or air kerma rate measurement related to the patient reference point, as specified in IEC 60601-2-43 standards. The error can occur only in systems equipped with a second (overhead) X-ray tube.
According to the manufacturer, this measurement error has no impact on clinical workflow or diagnostic accuracy. Facilities using affected equipment should contact Siemens Medical Solutions for guidance on verification and any necessary remediation steps.
The recalled product
- Product
- Luminos dRF Max (VE10, VF10, VF11)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
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: 10762471
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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