FDA-Device2019-03-27Class II
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)>
Fujifilm Medical Systems U.S.A., Inc.
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.
Sold states
US Nationwide Distribution
Affected count
56 units
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2019Don't want to check this manually?
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