FDA Device recall Z-1958-2019
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…
- FDA Device
- Class II
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of 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… by Canon Medical System Usa, citing 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 transmissi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1958-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-16 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | No./Serial No./Manufacture Date: No 1./U8A1312001/JANUARY 2013; No.2/U8A1312002/JANUARY 2013; No.3/U8A1342003/APR…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1958-2019%22
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