FDA-Device2018-09-12Class II
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
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.
Sold states
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
Affected count
43
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2964-2018Don't want to check this manually?
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