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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 62989
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
Letter
Distribution Pattern US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054 Class II During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt to the floor on one side. 9 Z-2367-2012
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