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Shimadzu Corporation Medical Systems Division FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems TClass IIOct 16, 2025Due to an issue (potential breakage) with the shaft for the |
| SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinaClass IISep 6, 2024X-ray R/F system software with certain versions of the contr |
| Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followinClass IISep 6, 2024If digital angiography system is used with a specific cathet |
| The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studieClass IISep 6, 2024X-ray R/F system software with certain versions of the contr |
| Shimadzu, Trinias, Digital Angiography SystemClass IIJan 29, 2024Due to capacitor manufacturing issue, their is a potential t |
| Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4Class IIApr 10, 2023Eight fixing bolts at the base of the X-ray ceiling tube col |