SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Medical Device Recall in 2024 - (Recall #: Z-0316-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 6, 2024

Date Posted: November 13, 2024

Recall Number: Z-0316-2025

Event ID: 95450

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.

Status: Ongoing

Product Quantity: 3

Code Information:

UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated