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U.S. Department of Health and Human Services

Class 2 Device Recall RADREXI DRAD3000E Digital Radiography System

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  Class 2 Device Recall RADREXI DRAD3000E Digital Radiography System see related information
Date Initiated by Firm April 18, 2018
Create Date August 31, 2018
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-2964-2018
Recall Event ID 80642
510(K)Number K122842  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Code Information SERIAL NO. LAST FOUR MANUFACTURE  DATE 1 U8A1312001 2001 JANUARY 2013 2 U8A1312002 2002 JANUARY 2013 3 U8A1342003 2003 APRIL 2013 4 U8A1362004 2004 JUNE 2013 5 U8B13X2006 2006 OCTOBER 2013 6 U8B13Z2008 2008 DECEMBER 2013 7 U8B1412009 2009 JANUARY 2014 8 U8B1432010 2010 MARCH 2014 9 U8B1442011 2011 APRIL 2014 10 U8B1462013 2013 JUNE 2014 11 U8B1472014 2014 JULY 2014 12 U8B1482015 2015 AUGUST 2014 13 U8B14Y2016 2016 NOVEMBER 2014 14 U8B14Z2017 2017 DECEMBER 2014 15 U8B14Z2018 2018 DECEMBER 2014 16 U8B14Z2019 2019 DECEMBER 014 17 U8B1522021 2021 FEBRUARY 2015 18 U8B1522022 2022 FEBRUARY 2015 19 U8B1522023 2023 FEBRUARY 2015 20 U8B1522024 2024 FEBRUARY 2015 21 U8B1612025 2025 JANUARY 2016 22 U8B1632026 2026 APRIL 2016 23 U8B1642027 2027 APRIL 2016 24 U8B1642028 2028 APRIL 2016 25 U8B1642029 2029 APRIL 2016 26 U8B1662030 2030 JUNE 2016 27 U8B16X2032 2032 NOVEMBER 2016 28 U8B1722033 2033 FEBRUARY 2017 29 U8B1752034 2034 MARCH 2014 30 U8B1762035 2035 JUNE 2017 31 U8B1782036 2036 AUGUST 2017 32 USA1462001 2001 JUNE 2014 33 USA1492002 2002 SEPTEMBER 2014 34 USA14Z2003 2003 DECEMBER 2014 35 USA1512004 2004 JANUARY 2015 36 USA1532005 2005 MARCH 2015 37 USA15Z2006 2006 DECEMBER 2015 38 USA1662007 2007 JUNE 2016 39 U8B1512020 3030 JANUARY 2015 40 U8B1677001 7001 JULY 2016 41 USA16Y2011 2011 NOVEMBER 2016 42 USA1682008 2008 AUGUST 2016 43 U8A1372005 2005 JULY 2013 44 USA16X2009 2009 OCTOBER 2016 45 USA16X2010 2010 OCTOBER 2010 46 U8B13X2007 2007 OCTOBER 2013
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact Terry Schultz
714-730-5000
Manufacturer Reason
for Recall		 It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.
FDA Determined
Cause 2		 Software design
Action On 04/18/2018, the firm mailed Urgent: Medical Device Correction letters via USPS return receipt mail. The letter contains a return reply form that is to be faxed. After one month contact will be made with each non-responding location and a copy of the letter will be faxed to that location and the fax receipt will serve as proof of notification. Upon release of the modified software it will be assigned to a firm employee with instructions for implementation at each site. Each incident is assigned unique service incident (case) and the completion of the service incidents are tracked through completion. In the event that a customer refuses the installation the customer would be requested to sign a service case record stating that the corrected software was refused.
Quantity in Commerce 43
Distribution Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia
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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