The Recall Desk

Manufacturer

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

6 recalls in our database name SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2025-11-19

Of the 6 recalls from SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–6 of 6

  • HighFDA (Devices)·Z-0499-2026·2025-11-19

    Ceiling X-ray tube supports recalled over a shaft that may break

    Shimadzu is recalling 1,766 ceiling type X-ray tube supports, models CH-200 and CH-200M, because the mounting shaft may break and the tube assembly could come off.

    Product
    Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic ex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2025·2024-11-13

    Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure

    Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.

    Product
    The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2025·2024-11-13

    X-ray System Software May Fail to Display Images During Mode Switching

    SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.

    Product
    SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2025·2024-10-30

    Shimadzu Trinias Unity Catheterization Table Movement Control Defect

    Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.

    Product
    Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2024·2024-03-20

    Shimadzu Trinias Digital Angiography System Recalled for Capacitor Defect

    Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.

    Product
    Shimadzu, Trinias, Digital Angiography System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2023·2023-08-09

    X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts

    Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.

    Product
    Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
    Category
    Medical Device
    Distribution
    Distributed nationwide