Reported Jul 17, 2019 · Terminated
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless
- FPD) Software versionv5.00ER005
- Product UsageThe 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
- Lot codes and dates
48 of 48 products
Products covered by this recall # Product as published 1 No 1./U8A1312001/JANUARY 2013 2 No.2/U8A1312002/JANUARY 2013 3 No.3/U8A1342003/APRIL 2013 4 No.4/U8A1362004 /JUNE 2013 5 No. 5 U8B13X2006/OCTOBER 2013 6 No. 6 U8B13Z2008/DECEMBER 2013 7 No. 7 U8B1412009/JANUARY 2014 8 No. 8 U8B1432010 /MARCH 2014 9 No. 9 U8B1442011/APRIL 2014 10 No.10 U8B1462013/JUNE 2014 11 No.11 U8B1472014/JULY 2014 12 No.12 U8B1482015/AUGUST 2014 13 No.13 U8B14Y2016/NOVEMBER 2014 14 No.14 U8B14Z2017/DECEMBER 2014 15 No.15 U8B14Z2018/DECEMBER 2014 16 No.16 U8B14Z2019/DECEMBER 2014 17 No.17 U8B1512020/JANUARY 2015 18 No.18 U8B1522021/FEBRUARY 2015 19 No.19 U8B1522022/FEBRUARY 2015 20 No.20 U8B1522023/FEBRUARY 2015 - Amount recalled
- 46
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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