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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 63042
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 2012-08-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Mobilett Mira. Mobile X-Ray System. Model number 10273100 -- serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112. Class II During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to replace motor drive handles and circuit board connection cables on all affected Mobilett Mira systems. 20 Z-2322-2012