The Recall Desk
ModerateFDA (Devices)·Z-1958-2019·Announced 2019-07-17

Canon Radrex-i X-Ray System Software Malfunction Recall

Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software malfunction that prevents image acquisition but does not report any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls without reported harm.

Plain-English summary

Canon Medical System, USA, INC. is recalling 46 units of the Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) with software version v5.00ER005. The recall involves a software malfunction that affects the system's ability to transmit images from the wireless flat panel detector (FPD).

The issue occurs when a user performs radiography using the wireless FPD. A message window appears on the monitor stating that image transmission was not completed and that no image is available. The window presents an "OK" button to reacquire image data and a "Cancel" button to cancel the acquisition. Selecting "OK" causes the same message window to reappear, prompting users to repeat the operation multiple times before selecting "Cancel" to exit the reacquisition mode.

The affected units were distributed nationwide in the United States, specifically in Pennsylvania, Utah, Florida, New York, Arkansas, Louisiana, West Virginia, New Jersey, Ohio, Michigan, Wisconsin, Tennessee, Texas, Vermont, Georgia, North Carolina, and Illinois. The recall covers 48 specific serial numbers manufactured between January 2013 and October 2016. Users should contact Canon Medical System for further instructions on resolving the software issue.

The recalled product

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 appropriat
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — X-Ray System
Hazard
Affected units
46

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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