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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65487
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 2013-02-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern United States Nationwide Distribution in the states of ND, OH and SC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography Model number 10140000, serial numbers 3118, 3243 and 3309 Class II Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this issue, and a Siemens Service Engineer has inspected the units and made any adjustments necessary. 3 Z-1694-2013