Z-2037-2012 Class II Terminated
FDA device recall Z-2037-2012 was initiated by Hitachi Medical Systems America Inc on May 4, 2012 and is designated Class II. 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 f… The recall status is terminated (terminated February 19, 2013). Affected quantity: Six (6) units.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- May 4, 2012
- Termination Date
- February 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Six (6) units
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.
Distribution Pattern
US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
Code Information
Serial #'s S5001 - S5011