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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie
Recalled November 13, 2024 · FDA recall Z-0317-2025 · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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. · FDA Class II
Units
30
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →