CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

Axiom Luminos dRFsystem The Axiom Luminos dRF is intended recalled

Siemens Medical Solutions USA is recalling Axiom Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal, distributed in 19 states. The recall was initiated on 11 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: 10094200, serial numbers:4332 4291 4323 4430 3061 4331 4238 4297 4201 4024 3098 4252 4372 4354 4077 3050 3108 4327 4342 4251 3053 3114 4156 3145 3096 4043 3181 4208 3090 4143 4051 4199 4401 4405 4151 4373 4276

Quantity recalled37

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1711-2014
FDA event ID: 68110
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Apr 2014
FDA classified: 4 Jun 2014
Reported: 11 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

11 Apr 2014	Recall initiated by company
4 Jun 2014	Classified by FDA	+54 days
11 Jun 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.

Product as listed by the FDA

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 examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

Where it was distributed

Class II Recall - US Distribution including the states of IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ.

California Colorado Florida Georgia Illinois Indiana Maine Michigan Minnesota Missouri New Jersey New York Ohio Oklahoma Oregon Pennsylvania Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Model number: 10094200, serial numbers:4332 4291 4323 4430 3061 4331 4238 4297 4201 4024 3098 4252 4372 4354 4077 3050 3108 4327 4342 4251 3053 3114 4156 3145 3096 4043 3181 4208 3090 4143 4051 4199 4401 4405 4151 4373 4276

Where was it sold?

Class II Recall - US Distribution including the states of IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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