FDAApril 18, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

canon medical systemcanoncanon medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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