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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Recall Number Z-1848-2013
Classification Class II
Code Info Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
Product Distributed Qty 4
Reason For Recall 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.

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 Letter
Distribution Pattern US Distribution including the states of CA, IN, NJ and OK.