FDA Device recall Z-2964-2018
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) by Canon Medical System Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2964-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-18 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Canon Medical System Usa |
| Distribution | AR, FL, GA, IL, LA, MI, NC, NJ, NY, OH, PA, TN, TX, UT, VT, WI, WV |
Product
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Reason
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.
Identifiers
| code_info | SERIAL NO. LAST FOUR MANUFACTURE…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2964-2018%22
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