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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Event Detail

Event ID 62988
Product Type Devices
Status Completed
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082. Class II Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor. 5 Z-2341-2012