Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is Recalled by Shimadzu Medical Systems Usa Com Due to Normal operation of the device is to power...
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 Medical Systems Usa Com directly.
Affected Products
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.
Quantity: 8 units
Why Was This Recalled?
Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shimadzu Medical Systems Usa Com
Shimadzu Medical Systems Usa Com has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report