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.
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- November 9, 2020
- Terminated
- December 16, 2022
- Recall Number
- Z-0549-2021
- Quantity
- 60 units
- Firm Location
- Tustin, CA
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
US Nationwide distribution. OUS: Unknown
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
Root Cause
Software design
Action Taken
On 11/9/2020, Canon issued a "Urgent: Medical Device Correction" letter to all affected customers via facsimile. In addition, to informing consignees about the recall, the firm ask affected consignees to take the following actions: 1. Until corrective action has been taken, in order to avoid the problem, please use the system with setting InstaView OFF according to the last notification (dated June 2020) Subject: Abnormality in Realtime Reconstruction Images. Please see Attachment A. 2. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. 3. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.