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U.S. Department of Health and Human Services

Class 2 Device Recall Canon Radrexi Digital Radiography System

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  Class 2 Device Recall Canon Radrexi Digital Radiography System see related information
Date Initiated by Firm October 16, 2018
Create Date July 11, 2019
Recall Status1 Terminated 3 on July 20, 2020
Recall Number Z-1958-2019
Recall Event ID 83193
510(K)Number K122842  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005

Product Usage:
The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.
Code Information No./Serial No./Manufacture Date:  No 1./U8A1312001/JANUARY 2013;  No.2/U8A1312002/JANUARY 2013;  No.3/U8A1342003/APRIL 2013;  No.4/U8A1362004 /JUNE 2013;  No. 5 U8B13X2006/OCTOBER 2013; No. 6 U8B13Z2008/DECEMBER 2013; No. 7 U8B1412009/JANUARY 2014; No. 8 U8B1432010 /MARCH 2014; No. 9 U8B1442011/APRIL 2014; No.10 U8B1462013/JUNE 2014; No.11 U8B1472014/JULY 2014; No.12 U8B1482015/AUGUST 2014; No.13 U8B14Y2016/NOVEMBER 2014; No.14 U8B14Z2017/DECEMBER 2014; No.15 U8B14Z2018/DECEMBER 2014; No.16 U8B14Z2019/DECEMBER 2014; No.17 U8B1512020/JANUARY 2015; No.18 U8B1522021/FEBRUARY 2015; No.19 U8B1522022/FEBRUARY 2015; No.20 U8B1522023/FEBRUARY 2015; No.21 U8B1522024/FEBRUARY 2015; No.22 U8B1612025/JANUARY 2016; No.23 U8B1632026/MARCH 2016; No.24 U8B1642027/APRIL 2016; No.25 U8B1642028/APRIL 2016; No.26 U8B1642029/APRIL 2016; No.27 U8B1662030 /JUNE 2016; No.28 U8B1677001/JULY 2016; No.29 U8B16X2032/OCTOBER 2016; No.30 U8B1722033 /FEBRUARY 2017; No.31 U8B1752034/MAY 2017; No.32 U8B1762035/JUNE 2017; No.33 U8B1782036 /AUGUST 2017; No.34 U8B17Z2037 /DECEMBER 2017; No.35 U8C1812038/JANUARY 2018; No.36 USA1462001/JUNE 2014; No.37 USA1492002/SEPTEMBER 2014; No.38 USA14Z2003/DECEMBER 2014; No.39 USA1512004/JANUARY 2015; No.40 USA1532005/MARCH 2015; No.41 USA15Z2006/DECEMBER 2015; No.42 USA1662007/JUNE 2016; No.43 USA1682008/AUGUST 2016; No.44 USA16X2009/OCTOBER 2016; No.45 USA16Y2011/NOVEMBER 2016; No.46 U8A1372005/JULY 2013; No.47 U8B13X2007/OCTOBER 2013; No.48 USA16X2010/OCTOBER 2016
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact Terry Schultz
714-669-4121
Manufacturer Reason
for Recall		 software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
FDA Determined
Cause 2		 Software design
Action On October 16, 2019, the firm sent an urgent medical device correction letter via USPS, return receipt to all customers who were distributed the affected device. The notification letter ask customers to do the following: 1. Should the problem occur before the modified software is installed on your system, please reduce the number of other devices which use the same wireless channel as this system as much as possible to avoid heavy wireless traffic. 2. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility 3. Please complete and return the customer reply form via email to RAffairs@us.medical.canon or by fax to regulatory affairs at 877-349-3054. 4. If you have any questions regarding the letter, please contact Terry Schultz, Regulatory Affairs Manager at (800) 421-1968 or contact your local Canon Representative at (800) 521-1968.
Quantity in Commerce 46
Distribution US Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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