Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or g

Recalled March 27, 2019 · FDA recall Z-1040-2019 · Fujifilm Medical Systems U.S.A

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. · FDA Class II

Units

56 units

Sold at

US Nationwide Distribution

Description

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.

Product

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)>

Manufacturer(s)

Fujifilm Medical Systems U.S.A., Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →