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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) V10.2 see related information
Date Initiated by Firm November 09, 2020
Create Date December 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-0549-2021
Recall Event ID 86864
510(K)Number K192832  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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.
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 Contact Ms. 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
Action 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.
Quantity in Commerce 60 units
Distribution US Nationwide distribution. OUS: Unknown
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Canon Medical Systems Corporation
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