Lower riskMedical device recall · FDA · Published April 18, 2018
Canon DRAD-3000E Wireless FPD: Image transmission failure during radiography
Canon recalls DRAD-3000E (Radrex-i) wireless flat panel detectors that show image transmission errors during radiography. Affected units have specific serial numbers and were sold from 2001 to 2016. No remedy is provided in this recall.
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.
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Contact the company
📍Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047
“Canon DRAD-3000E Wireless FPD: Image transmission failure during radiography.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71368-canon-drad-3000e-wireless-fpd-image-transmission-failure-during-radiography. Based on FDA recall #Z-2964-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2964-2018%22&limit=1).
The FDA announced on April 18, 2018, that Canon Medical System, USA, INC. is recalling DRAD-3000E (Radrex-i) TFP-4336W wireless flat panel detectors due to a software error that prevents image transmission. The agency classified the recall as Class II.
Serial numbers: U8A1312001 through U8B1782036, USA1462001 through USA16X2010, U8B1512020, U8B1677001
Manufacture dates: January 2013 through February 2015
Quantity: 43 units
The hazard
When an operator performs radiography, the monitor displays a message stating image transmission was not completed and no image is shown. The system presents OK and Cancel buttons to reacquire or quit the mode; selecting OK causes the same error message to reappear repeatedly.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has 27 other recalls on record since May 30, 2018. Recent brand recalls include a August 26, 2026 recall of the Canon Alphenix INFX-8000C/B5 for tabletop shift risk and an August 4, 2026 recall of Canon Alphenix X-ray Systems for loose fixing screws. Other recent recalls of similar products include a March 3, 2026 Philips Xper FD20 X-ray System Recall and a March 3, 2026 PHILIPS ALLURA Xper FD10 X-ray System recall.
How to tell if you have this one
Check the serial number on the device. Affected units have specific serial numbers listed in the recall, including last four digits and a manufacture date between January 2013 and February 2015.
Brand
Canon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for the serial number on the device, which includes the last four digits and manufacture date.
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: 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 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2964-2018 (April 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2964-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.