SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiogra

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.

Details from the source

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. 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. Quantity: 3 Lot/code info: UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001

UPC codes

04540217064809, 04540217064816

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.