FDAJanuary 15, 2019device

Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

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

The hazard

FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.

What to do

FDA enforcement status: Terminated

Brands named

fujifilm medical systems ufujifilmfujifilm medical

Recall history

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

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