4 results
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42ms
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Sources: EU EUDAMED, US FDA
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)>
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·March 27, 2019
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)>
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code IZL·January 15, 2019
JOYSUN GROUP S.L.U
Authorized representative
🇪🇸 Spain·15 Manufacturers·274 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices