44 results
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51ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Shimadzu Medical Systems·January 4, 2017
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·January 4, 2017
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
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
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
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
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
FDA Recall
Terminated
·Shimadzu Medical Systems·Product code IZI·April 3, 2014
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
FDA Recall
Terminated
·Shimadzu Medical Systems·Product code IXR·March 31, 2016
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
FDA Recall
Terminated
·Shimadzu Medical Systems·Product code JAA·September 30, 2015
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
FDA Recall
Terminated
·Shimadzu Medical Systems·Product code IZI·January 12, 2018