PlainRecalls
FDA Devices Moderate Class II Terminated

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Reported: September 12, 2018 Initiated: April 18, 2018 #Z-2964-2018

Product Description

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Reason for 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.

Details

Units Affected
43
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
Location
Tustin, CA

Frequently Asked Questions

What product was recalled? ▼
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD). Recalled by Canon Medical System, USA, INC.. Units affected: 43.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2964-2018.

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