Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The FLUOROspeed is intended to be used as a universal Recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Due to X-ray R/F system software with certain versions of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION directly.
Affected Products
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.
Quantity: 30
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report