The Recall Desk

Manufacturer

Shimadzu Medical Systems

26 recalls in our database name Shimadzu Medical Systems as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
1
Most recent
2026-06-10

Of the 26 recalls from Shimadzu Medical Systems we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • HighFDA (Devices)·Z-2294-2026·2026-06-10

    Digital angiography and radiography systems may remain energized when switched off

    Digital angiography and radiography systems are being recalled because contactors in the high voltage generator may weld together, leaving the power supply energized when the system is off.

    Product
    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/D15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2022·2022-04-13

    X-ray System Models Recalled for Potential Radiation Dose Exceeding Standards

    Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.

    Product
    MODEL: X-RAY TV SYSTEM SONIALVISION G4
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0869-2022·2022-04-13

    X-ray System Radiation Dose May Exceed Safety Limits in Some Modes

    Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.

    Product
    MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0867-2022·2022-04-13

    X-ray fluoroscopy system may deliver excessive radiation dose

    Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.

    Product
    MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0654-2022·2022-03-09

    Digital Angiography System Generators May Emit Excessive X-Ray Radiation

    Shimadzu Medical Systems is recalling Digital Angiography System generators due to potential excessive x-ray radiation in fluoroscopic mode. Installation issues may cause radiation dose rates to exceed safe limits.

    Product
    Digital Angiography System Bransist safire Generator Model D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0655-2022·2022-03-09

    Digital Angiography System generator may exceed safe radiation dose rates

    Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.

    Product
    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0534-2021·2020-12-16

    Shimadzu Mobile X-Ray System Recalled for Improper Handle Bolts

    Shimadzu Medical Systems is recalling 115 Mobile X-Ray Systems because the adjustable handle may have improper bolts, posing a risk of harm to individuals around the device.

    Product
    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 emergen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2021·2020-12-16

    Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

    Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    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 w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2021·2020-12-16

    Shimadzu Bransist Safire Digital Angiography System Recalled for Software Defect

    Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2021·2020-12-16

    Shimadzu MH-200S X-Ray System Recalled for Ceiling Arm Software Defect

    Shimadzu Medical Systems is recalling 22 MH-200S X-Ray systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2591-2020·2020-07-22

    Shimadzu Recalls Three Trinias DAP Meters for Tolerance Issues

    Shimadzu Medical Systems is recalling three Trinias DAP Meters because they were found to be outside of tolerance. The devices are used in interventional procedures.

    Product
    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2018·2018-06-20

    Shimadzu Sonialvision Safire II X-ray System Recalled for Irradiation Display Error

    Shimadzu Medical Systems is recalling 17 Sonialvision Safire II angiographic x-ray systems because the irradiation time and integral dose displays may reset to zero during serial radiography.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2017·2017-01-04

    Shimadzu X-ray High Voltage Generator Recalled for Oil Leak Risk

    Shimadzu Medical Systems is recalling 13 X-ray high voltage generators due to a potential oil leak from the x-ray tube housing.

    Product
    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.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0917-2017·2017-01-04

    Shimadzu X-ray TV System Recalled for Oil Leak Risk

    Shimadzu Medical Systems is recalling 39 SONIALVISION G4 X-ray TV Systems due to a potential oil leak from the x-ray tube housing.

    Product
    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1585-2016·2016-05-04

    Shimadzu X-Ray Diagnostic Table Recalled for Unintentional Reverse Tilting

    Shimadzu Medical Systems is recalling 185 X-Ray Diagnostic Tables (Model YSF-300) due to reports of unintentional movement to reverse tilting.

    Product
    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 radiogr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0451-2016·2015-12-30

    Shimadzu Mobile X-ray Systems Recalled for Image Transfer Issues

    Shimadzu Medical Systems is recalling 297 Mobile X-ray systems because images may not transfer properly to the image server.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0251-2016·2015-11-18

    Shimadzu C-arm Table Recall Due to Interference Risk

    Shimadzu Medical Systems is recalling 26 C-arm Tables because the C-arm may interfere with the table top under certain circumstances.

    Product
    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1569-2014·2014-05-14

    Shimadzu Digital Radiography X-Ray System Recalled for Image Loss

    Shimadzu Medical Systems is recalling its Digital Radiography X-Ray System because a report was received regarding lost images under certain circumstances.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1150-2014·2014-03-12

    Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk

    Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2013·2013-06-12

    Shimadzu Mobile X-ray Systems Recalled for Loose Internal Screws

    Shimadzu Medical Systems is recalling 200 Mobile DaRt Evolution X-ray systems due to a potential risk of internal screws becoming loose.

    Product
    Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0264-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 5 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0265-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 3 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0262-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu is recalling 288 mobile X-ray systems and related components because they may not meet federal standards for beam quality.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0261-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance standards for beam quality.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0260-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu Medical Systems is recalling 665 R-30H Diagnostic X-Ray Beam-Limiting Devices because they may not comply with 2006 product performance standards regarding beam quality.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide