SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studi…

Recall date

September 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0317-2025

FDA classification

Class II

Brand / firm

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.