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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Recall Number Z-1638-2014
Classification Class II
Code Info (Material number 10549894) with serial numbers 5000 through 5029.
Product Distributed Qty 5
Reason For Recall There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.

Event Detail

Event Id 68224
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 2014-04-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of GA, FL, NY, NV, and MA.