Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0316-2025·Announced 2024-11-13

X-ray System Software May Fail to Display Images During Mode Switching

SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall of a software malfunction with no reported illnesses or injuries. The defect is an operational issue rather than a direct safety hazard, causing occasional image display failures that may delay examinations but present no direct patient harm.

Plain-English summary

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION is recalling certain units of the SONIALVISION G4, a multi-purpose X-ray system used for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations.

The software controlling the device may occasionally fail to display images when switching from fluoroscopy mode to radiography mode. This functional failure may result in examination delays or cancellations.

Three units have been identified with this software issue. Affected serial numbers are 41C3518D7001, 41C3518E4001, and 41C3536D9001. The equipment has been distributed nationwide to medical facilities in California, Connecticut, Massachusetts, West Virginia, Ohio, New York, Iowa, Nebraska, Minnesota, Illinois, Florida, North Carolina, Hawaii, Louisiana, Maryland, Montana, Washington, Arkansas, Texas, Tennessee, and Colorado.

Affected healthcare facilities should contact SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION for information regarding this software issue.

The recalled product

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.
Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Category: Medical Device — Diagnostic Imaging
Hazard: display-failure
examination-delay
Affected units: 3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

UDI-DI: 04540217064809
04540217064816. Serial Numbers: 41C3518D7001
41C3518E4001
41C3536D9001

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Part of a larger recall action

This product is one of 2 recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

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