FDAJanuary 14, 2019device

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 bein...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

shimadzu medical systems usa comshimadzushimadzu medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 bein... — Recall Details · AllClear