Canon Medical System, USA, INC. recalls DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Recall date

April 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2964-2018

FDA classification

Class II

Brand / firm

Canon Medical System, USA, INC.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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