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Shimadzu Medical Systems Recalls
26 recalls on record · November 14, 2012 to June 10, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 10, 2026Medical DevicesFDA
Shimadzu Medical Systems recalls Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-
Hazard: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
April 13, 2022Medical DevicesFDA
Shimadzu Medical Systems recalls MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Hazard: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
April 13, 2022Medical DevicesFDA
Shimadzu Medical Systems recalls MODEL: X-RAY TV SYSTEM SONIALVISION G4
Hazard: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
April 13, 2022Medical DevicesFDA
Shimadzu Medical Systems recalls MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Hazard: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
March 9, 2022Medical DevicesFDA
Shimadzu Medical Systems recalls Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Hazard: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
March 9, 2022Medical DevicesFDA
Shimadzu Medical Systems recalls Digital Angiography System Bransist safire Generator Model D150GC-40
Hazard: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
December 16, 2020Medical DevicesFDA
Shimadzu Medical Systems recalls MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neur
Hazard: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
December 16, 2020Medical DevicesFDA
Shimadzu Medical Systems recalls Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be
Hazard: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
December 16, 2020Medical DevicesFDA
Shimadzu Medical Systems recalls Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designe
Hazard: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
December 16, 2020Medical DevicesFDA
Shimadzu Medical Systems recalls Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product
Hazard: There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
July 22, 2020Medical DevicesFDA
Shimadzu Medical Systems recalls Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is
Hazard: The DAP meters were found to be outside of tolerance.
June 20, 2018Medical DevicesFDA
Shimadzu Medical Systems recalls Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used
Hazard: When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
January 4, 2017Medical DevicesFDA
Shimadzu Medical Systems recalls Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray
Hazard: Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
January 4, 2017Medical DevicesFDA
Shimadzu Medical Systems recalls Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Hazard: Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.
May 4, 2016Medical DevicesFDA
Shimadzu Medical Systems recalls X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit,
Hazard: Report of unintentional movement of table to reverse tilting.
December 30, 2015Medical DevicesFDA
Shimadzu Medical Systems recalls Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician
Hazard: The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
November 18, 2015Medical DevicesFDA
Shimadzu Medical Systems recalls Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Hazard: The C-arm may interfere with the table top under certain circumstances.
May 14, 2014Medical DevicesFDA
Shimadzu Medical Systems recalls Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography
Hazard: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
March 12, 2014Medical DevicesFDA
Shimadzu Medical Systems recalls Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take ge
Hazard: Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.
June 12, 2013Medical DevicesFDA
Shimadzu Medical Systems recalls Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiograph
Hazard: The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
November 14, 2012Medical DevicesFDA
Shimadzu Medical Systems recalls 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of
Hazard: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
November 14, 2012Medical DevicesFDA
Shimadzu Medical Systems recalls 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of pati
Hazard: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
November 14, 2012Medical DevicesFDA
Shimadzu Medical Systems recalls 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The de
Hazard: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
November 14, 2012Medical DevicesFDA
Shimadzu Medical Systems recalls 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Cl
Hazard: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
November 14, 2012Medical DevicesFDA
Shimadzu Medical Systems recalls R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1
Hazard: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
November 14, 2012Medical DevicesFDA
Shimadzu Medical Systems recalls R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/
Hazard: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.