Z-0549-2021 Class II Terminated
FDA device recall Z-0549-2021 was initiated by Canon Medical System, USA, INC. on November 9, 2020 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated December 16, 2022). Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- November 9, 2020
- Termination Date
- December 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution. OUS: Unknown
Code Information
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