Agency classClass IIOur severity:High FDA (Devices)·Z-1711-2014·Announced 2014-06-11

Siemens AXIOM Luminos dRFsystem Recalled for Electrostatic Discharge Risk

Siemens is recalling 37 AXIOM Luminos dRF diagnostic imaging systems because electrostatic discharges may trigger unintended movement, posing a danger to patients and personnel.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (unintended movement posing danger to patients and personnel) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 37 units of the AXIOM Luminos dRFsystem. This device is a universal diagnostic imaging system intended for radiographic and fluoroscopic studies, including general radiography/fluoroscopy, angiography, and pediatric examinations. The affected units are identified by model number 10094200 and specific serial numbers listed in the recall documentation.

The recall was initiated because it was determined that under rare environmental conditions—specifically extremely dry air in combination with a highly isolated floor—electrostatic discharges (ESD) greater than 8 kV may trigger an unintended movement of the system. This unintended movement may lead to an emergency situation and pose a danger to patients, operating personnel, or the unit itself.

The recall covers units distributed in the United States, including the states of Illinois, Virginia, Tennessee, Pennsylvania, Texas, Minnesota, Georgia, Michigan, Indiana, Ohio, Florida, California, Oregon, New York, Maine, Missouri, Oklahoma, Colorado, and New Jersey. Siemens is the recalling firm. The source text does not specify instructions for consumers or healthcare facilities regarding immediate actions to take, such as stopping use or contacting the manufacturer, but the hazard description indicates a risk of physical injury or equipment damage.

The recalled product

Product: AXIOM Luminos dRFsystem 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 R/F, angiography and pediatric…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging
Hazard: unintended-movement
electrostatic-discharge
physical-injury
Affected units: 37

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 number: 10094200

Distribution

Distributed in 19 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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