Nov

2024

FDA Recall: X-Ray R/F System Control Board Failing to Display Images

Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Date of Enforcement Report: 11/07/2024
Class II

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.

Recall Number:

Z-0316-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

VOLUME OF PRODUCT IN COMMERCE:

DISTRIBUTION:

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: X-Ray R/F System Control Board Failing to Display Images

Allison Pate

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