FDAFDA · Food and drugs·Recall number Z-0316-2025
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.
Published November 13, 2024 · Recall initiated: September 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Distributor
- 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.
- Lot
- UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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