BEUDAMED
    39 results · 51ms · Sources: EU EUDAMED, US FDA

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    Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZO·November 20, 2016

    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code JAA·November 20, 2016

    0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZL·October 28, 2011

    0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZL·October 28, 2011

    Shimadzu, Trinias, Digital Angiography System

    FDA Recall
    Open, Classified ·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku·Product code OWB·January 29, 2024

    0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZL·October 28, 2011

    0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZL·October 28, 2011

    Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZL·November 10, 2015

    R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZX·October 28, 2011

    R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZW·October 28, 2011

    Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZL·November 15, 2013

    SHIMADZU MobileDaRt Evolution (MX8 Version), 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 ·Shimadzu Medical Systems Usa Com·Product code IZL·January 14, 2019

    Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The 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.

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code IZL·November 9, 2020

    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code IZI·November 18, 2020

    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code OWB·November 18, 2020

    MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code IZI·November 18, 2020

    TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code OWB·June 15, 2018

    Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code OWB·April 20, 2026

    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code KPR·May 23, 2017

    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code KPR·May 23, 2017