Canon Medical System, USA, INC. recalls Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-

Hazard / Issue

A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial Numbers: 8LA2052063, 8LA19Z2034 , 8LA19X2004, 8LA19Z2027, 8LA19Z2029, 8LA2052062, 8LA2042055, 8LA19Z2032, 8OA2052059, 8LA2042051, 8LA2032044, 8LA19X2002, 1LB1922175, 8LA2042050, 8LA19X2007, 8LA2012037, 8LA19Y2021, 8LA19Y2014, 8LA2042056, 8LA19Z2023, 8LA2052067, 8LA19Z2031, 8LA19Y2019, 8LA19Z2030, 8OA19Y2013, 8LA19Z2028, 8LA19Y2012, 8LA19Y2020, 8LA2032042, 8LA2052066, 8LA19X2003, 8LA19Y2022, 8LA19X2008, 8LA2042047, 8LA19Z2024, 8LA2032046, 8LA19Z2033, 8OA2042053, 8LA2012036, 8LA2042054, 8LA19Z2025, 8LA19Z2026, 8LA2022041, 8LA19X2010, 8LA2032043, 8OA19X2001, 8OA2052061, 8OA2042049, 8LA19Y2016, 8LA2022039, 8LA19Y2015, 8LA2012035, 8LA2032045, 8LA19Y2018, 8LA19X2005, 8LA19X2006, 8LA19X2009, 8LA19Y2011, 8LA19Y2017, 8LA2012038, 8LA2052060, 8LA2052058 , 8LA2052064, 8LA2052065, 8LA2052068, 8LA2022040, 8OA2042052, 8LA2042048, 8LA2052057