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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Canon Medical System, USA, INC.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1958-2019
Related Recalls
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Canon Medical System, USA
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical System, USA
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.