Recall Z-0316-2025— SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Name: FDA recall Z-0316-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-06

Class II · Ongoing

Class II FDA medical device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, initiated 2024-09-06. It names one FDA 510(k) clearance: K190373. 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.. 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: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Classification: Class II
Status: Ongoing
Initiated: 2024-09-06
Firm location: Kyoto, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K190373 — SonialVision G4Shimadzu Corporation·cleared 2019-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.