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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Event Detail

Event ID 62372
Product Type Devices
Status Ongoing
Recalling Firm Hitachi Medical Systems America Inc
City Twinsburg
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-04
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Serial #'s S5001 - S5011 Class II Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data. Six (6) units Z-2037-2012