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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion Prime SP (TSX303B8/8L) V10.2

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 Class 2 Device Recall Aquilion Prime SP (TSX303B8/8L) V10.2see related information
Date Initiated by FirmNovember 09, 2020
Create DateDecember 09, 2020
Recall Status1 Terminated 3 on December 16, 2022
Recall NumberZ-0549-2021
Recall Event ID 86864
510(K)NumberK192832 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductCanon 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.
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 
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information ContactMs. Terry Schultz
800-421-1968
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce60 units
DistributionUS Nationwide distribution. OUS: Unknown
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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