Recall Z-2037-2012— Hitachi Medical Systems America Inc

Name: FDA recall Z-2037-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-04

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2012-05-04, terminated 2013-02-19. It names one FDA 510(k) clearance: K101888. 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.. 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: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2012-05-04
Terminated: 2013-02-19
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K101888 — SCENARIA WHOLE-BODY X-RAY CT SYSTEMHitachi Medical Systems America, Inc.·cleared 2011-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.