Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · Japan · 2024-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0316-2025
Date of alert
2024-09-06
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04540217064809
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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