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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65491
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 2013-05-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution including the states of CA, IN, NJ and OK.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system Model number 10094200, serial numbers 4024, 4077, 4043 and 4051 Class II Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected. 4 Z-1848-2013