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.
This recall has been terminated (originally issued July 19, 2012).
- Recall Initiated
- May 4, 2012
- Posted
- July 19, 2012
- Terminated
- February 19, 2013
- Recall Number
- Z-2037-2012
- Quantity
- Six (6) units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
Lot / Code Info
Serial #'s S5001 - S5011
Root Cause
Software design
Action Taken
Hitachi sent a "Device Correction Notice" dated May 4, 2012 to their customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to "not use the Reconstruction Status" function to suspend active reconstructions until the software problem can be corrected. They also informed their customers that a representative will visit their facility to install the software update to permanently resolve the issue at no cost to the facility. For further information regarding this notice call 800-800-3106 x3720.