DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Medical device recall Z-2964-2018. Published in FDA’s Enforcement Report on Sep 12, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 12, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 17 states named in where it went
- 43 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
43, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,467 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
17 states and territories.
Every one of them
- Arkansas
- Florida
- Georgia
- Illinois
- Louisiana
- Michigan
- North Carolina
- New Jersey
- New York
- Ohio
- Pennsylvania
- Tennessee
- Texas
- Utah
- Vermont
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 18, 2018.
- FDA classified it on Aug 31, 2018.
- FDA’s Enforcement Report published it on Sep 12, 2018.
- FDA terminated it on May 13, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Canon Medical System, USA, INC., of Tustin, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.