DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
FDA Device Recall #Z-2964-2018 — Class II — April 18, 2018
Recall Summary
| Recall Number | Z-2964-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 18, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Canon Medical System, USA, INC. |
| Location | Tustin, CA |
| Product Type | Devices |
| Quantity | 43 |
Product Description
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
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.
Distribution Pattern
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
Lot / 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
Other Recalls from Canon Medical System, USA, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1018-2026 | Class II | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | Dec 19, 2025 |
| Z-1178-2026 | Class II | Alphenix INFX-8000H, interventional fluoroscopi... | Dec 19, 2025 |
| Z-1017-2026 | Class II | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | Dec 19, 2025 |
| Z-1177-2026 | Class II | Alphenix INFX-8000F, interventional fluoroscopi... | Dec 19, 2025 |
| Z-1179-2026 | Class II | Alphenix INFX-8000V, interventional fluoroscopi... | Dec 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.