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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Event Detail

Event ID 68110
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II 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. 37 Z-1711-2014
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