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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Shimadzu SONIALVISION G4 and FLUOROspeed X-rays Recalled for Display Issues

Agency Publication Date: November 7, 2024
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Summary

Shimadzu Corporation Medical Systems Division is recalling 33 units of SONIALVISION G4 and FLUOROspeed X-ray systems due to a software defect. The systems may occasionally fail to display images when switching from Fluoroscopy to Radiography mode, which can cause delays or cancellations of medical examinations. No incidents or injuries have been reported in connection with this issue. The recall affects specific diagnostic imaging systems sold to medical facilities between September 2024 and the present.

Risk

The software failure prevents images from appearing on the display during mode switches, potentially interrupting critical medical procedures and delaying necessary diagnosis or patient treatment.

What You Should Do

  1. This recall affects Shimadzu SONIALVISION G4 and FLUOROspeed X-ray diagnostic imaging systems with specific serial numbers.
  2. Identify affected units by checking the serial number or UDI-DI code on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled systems and contact your authorized Shimadzu Medical Systems dealer or the manufacturer to arrange for a software correction.
  4. Follow any temporary operational instructions provided in the notification letter sent by Shimadzu Corporation until the software update is applied.
  5. Call the FDA at 1-888-463-6332 for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SONIALVISION G4 X-ray R/F system
Serial Numbers:
41C3518D7001
41C3518E4001
41C3536D9001
UDI:
04540217064809
04540217064816

A multi-purpose X-ray system suitable for general radiography and pediatric examinations.

Product: FLUOROspeed X-ray system
Serial Numbers:
MQ493E3E3001
MQ493E3E3002
MQ493E3D6002
MQ493E3D5001
MQ493E3D8002
MQ493E3E1002
MQ493E3D4002
MQ493E3D6003
MQ493E3DA002
MQ493E3E2001
MQ493E3E2002
MQ493E3E1001
MQ493E3DC001
MQ493E3D9001
MQ493E3D4005
MQ493E3D7001
MQ493E3DB002
MQ493E3D2002
MQ493E3D4001
MQ493E3D7002
MQ493E3D4003
MQ493E3D4004
MQ493E3D2001
MQ493E3D8001
MQ493E3D5002
MQ493E3DB001
MQ493E3D2003
MQ493E3DA001
MQ493E3D6001
MQ493E3E1003
UDI:
04540217065271

Universal diagnostic imaging system used for general R/F, angiography, and pediatric examinations.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95450
Status: Active
Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sold By: Authorized Shimadzu Medical Systems dealers
Manufactured In: Japan
Units Affected: 2 products (3; 30)
Distributed To: California, Connecticut, Massachusetts, West Virginia, Ohio, New York, Iowa, Nebraska, Minnesota, Illinois, Florida, North Carolina, Hawaii, Louisiana, Maryland, Montana, Washington, Arkansas, Texas, Tennessee, Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.