SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-19FDA-DeviceClass IICeiling 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 examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and di
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.
- 2024-11-13FDA-DeviceClass IIThe 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 emergency treatment on an outpatient basis, as well as for bedside examinations.
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.
- 2024-11-13FDA-DeviceClass IISONIALVISION 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.
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.
- 2024-10-30FDA-DeviceClass IITrinias 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.
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.
- 2024-03-20FDA-DeviceClass IIShimadzu, Trinias, Digital Angiography System
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
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