Hitachi Medical Systems America Inc: Medical Device Recall in 2012 - (Recall #: Z-2037-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 4, 2012

Date Posted: July 25, 2012

Recall Number: Z-2037-2012

Event ID: 62372

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.

Status: Terminated

Product Quantity: Six (6) units

Code Information:

Serial #'s S5001 - S5011

Distribution Pattern:

US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.

Voluntary or Mandated:

Voluntary: Firm initiated