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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina
Recalled November 13, 2024 · FDA recall Z-0316-2025 · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Hazard
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. · FDA Class II
Units
3
Sold at
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.
Description
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.
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(s)
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →