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Canon Medical System, USA, INC. recalls DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Recalled September 12, 2018 · FDA recall Z-2964-2018 · Canon Medical System, USA
Hazard
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. · FDA Class II
Units
43
Sold at
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
Description
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.
Product
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →