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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Recalls
6 recalls on record · August 9, 2023 to November 19, 2025 · 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.
November 19, 2025Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T
Hazard: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
November 13, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie
Hazard: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
November 13, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina
Hazard: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
October 30, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin
Hazard: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
March 20, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Shimadzu, Trinias, Digital Angiography System
Hazard: Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
August 9, 2023Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4
Hazard: Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.