| 2025-10-16 |
Class II
|
Ongoing |
Z-0499-2026 |
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T… |
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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 s… |
| 2024-09-06 |
Class II
|
Ongoing |
Z-0317-2025 |
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie… |
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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… |
| 2024-09-06 |
Class II
|
Ongoing |
Z-0316-2025 |
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina… |
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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… |
| 2024-09-06 |
Class II
|
Ongoing |
Z-0139-2025 |
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin… |
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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 dire… |
| 2024-01-29 |
Class II
|
Ongoing |
Z-1292-2024 |
Shimadzu, Trinias, Digital Angiography System |
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Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. |
| 2023-04-10 |
Class II
|
Ongoing |
Z-2270-2023 |
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4… |
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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 b… |