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:
3
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.
