Device 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.
Z-0316-2025
Product summary
- Event
- Event 95450
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0316-2025
Official wording
Reason: 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.
Code information: UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
Distribution pattern: US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
Derived failure modes
-
Device software or design
software with certain versions of the control board may occasionally fail to