The Recall Desk
ModerateFDA (Devices)·Z-2649-2014·Announced 2014-09-24

Siemens Axiom Luminos dRF Recalled for Fluid Infiltration Malfunction Risk

Siemens is recalling 33 Axiom Luminos dRF systems because fluid exposure to the tableside control panel may cause a malfunction and automatic shutdown.

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: The recall is classified as FDA Class II, and the source text describes a malfunction that results in an automatic shutdown rather than a direct injury or death, fitting the criteria for a moderate severity risk of harm where injury has not been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 33 units of the AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max. These devices are intended to be used as universal diagnostic imaging systems for radiographic and fluoroscopic studies, including general radiography, fluoroscopy, angiography, and pediatric examinations.

The recall was initiated because a potential malfunction may occur if the tableside control is exposed to fluids. Fluid may infiltrate the tableside control panel, resulting in a malfunction. In the unlikely event of fluid infiltration, a permanent short circuit within the control panel will automatically disable the system.

The affected units were distributed nationwide, including in Illinois, Virginia, Tennessee, Pennsylvania, Texas, Indiana, Minnesota, New Mexico, Georgia, Michigan, Florida, California, New York, Maine, Oklahoma, Missouri, New Jersey, and Arizona. Users of these devices should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential fluid infiltration risk.

The recalled product

Product
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general
Affected units
33

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 (2)

  • model # 10094200
  • see distribution list for individual device serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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