Recall Z-2037-2012 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
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 so
| Date | Jul 19, 2012 (initiated May 4, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | Six (6) units |
| Distribution | US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101888 | SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc., Apr 8, 2011 |