Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment Recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Due to X-ray R/F system software with certain versions of...

Date: September 6, 2024
Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION directly.

Affected Products

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.

Quantity: 3

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report