CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report

Drad-3000E (Radrex-i) Tfp-4336W (Wireless Fpd) recalled

Canon Medical System USA is recalling Drad-3000E (Radrex-i) Tfp-4336W (Wireless Fpd), distributed in 17 states. The recall was initiated on 18 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSERIAL 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

Quantity recalled43

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2964-2018
FDA event ID: 80642
Recalling firm: Canon Medical System USA, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Apr 2018
FDA classified: 31 Aug 2018
Reported: 12 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Apr 2018	Recall initiated by company
31 Aug 2018	Classified by FDA	+135 days
12 Sep 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Where it was distributed

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

Arkansas Florida Georgia Illinois Louisiana Michigan North Carolina New Jersey New York Ohio Pennsylvania Tennessee Texas Utah Vermont Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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