Company:Hitachi Medical Systems America Inc.
Date of Enforcement Report 7/25/12
Class ll:

PRODUCT
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. Z-2037-2012

REASON
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.

RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc., Twinsburg, OH on 5/4/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6 units

DISTRIBUTION
Nationwide

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