Device Recall Hitachi Scenaria CT System Software 의 리콜

Recall

62372

Class 2

Z-2037-2012

2012-05-04

2012-07-19

Terminated

United States

2013-02-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110356

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.

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.