FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0316-2025
·
Reported November 13, 2024
Enforcement
- Recall Number
- Z-0316-2025
- Event ID
- 95450
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2024
- Initiation Date
- September 6, 2024
- Classification Date
- November 7, 2024
- Address
- Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, N/A, Japan
Description
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.
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 Info
UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
Distribution
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.
Quantity
3