Lower risk Medical device recall · FDA · Published October 16, 2018

Canon Radrex-i X-Ray System Software v5.00ER005: Image Transmission Failure Risk

Canon recalls Radrex-i X-Ray System software version v5.00ER005 due to image transmission failures during radiography. Affected units display error messages repeatedly when using wireless flat panel detectors.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1958-2019Medical device Canon Medical ›

Lower-risk 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.

Take action

Contact the company

Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

✎ GovInfoNow plain-language explainer

Canon is recalling its Radrex-i X-Ray System software version v5.00ER005 because it causes repeated image transmission errors during radiography. This could lead to incomplete scans and unnecessary rework for medical staff. Read more at govinfonow.com/recall/69618-canon-radrex-i-x-ray-system-software-v5-00er005-image.

Source Summary by GovInfoNow · govinfonow.com/recall/69618-canon-radrex-i-x-ray-system-software-v5-00er005-image · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1958-2019

Cite this page

“Canon Radrex-i X-Ray System Software v5.00ER005: Image Transmission Failure Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69618-canon-radrex-i-x-ray-system-software-v5-00er005-image. Based on FDA recall #Z-1958-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1958-2019%22&limit=1).

The FDA announced on Oct. 16, 2018, that Canon Medical System USA Inc. is recalling Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission. The agency said the issue causes error messages to appear repeatedly during radiography procedures.

How to tell if you have it

Brand: Canon Medical
Product: Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD)
Software version: v5.00ER005
Units affected: 46
Serial numbers and manufacture dates: 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

The hazard

The FDA said a software malfunction causes a message window to display stating image transmission was not completed when users perform radiography. The system also shows buttons to reacquire or cancel the acquisition, but selecting "OK" prompts the same message window to appear again.

Context

GovInfoNow's records show Canon Medical System USA Inc. has 27 other recalls on record since April 18, 2018. Other recent recalls of similar products include Philips Azurion Systems R3.0 Software Issues (Dec. 8, 2025), Philips Azurion System Software R3.1 May Cause Imaging Loss (Dec. 12, 2025), and Philips Azurion 5 M20 X-ray System May Not Start Properly (March 3, 2026).

How to tell if you have this one

Check if your Radrex-i X-Ray System has software version v5.00ER005. The system may be identified by serial numbers listed in the recall notice (e.g., U8A1312001, U8B14Z2017).

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by checking the device settings or documentation. The affected version is v5.00ER005.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 17 states.

FDA distribution: “US Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, Florida, Georgia, Illinois, Louisiana, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Oct 16, 2018Firm started the recall
Jul 11, 2019FDA classified it Class II
Jul 17, 2019Published in FDA’s Enforcement Report
Jul 20, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69618-canon-radrex-i-x-ray-system-software-v5-00er005-image">Canon Radrex-i X-Ray System Software v5.00ER005: Image Transmission Failure Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1958-2019 (October 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1958-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.