Shimadzu Medical Systems Usa Com product recalled over fire hazard

Recall date

January 14, 2019

Source

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

Official notice title

Shimadzu Medical Systems Usa Com recalls BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualizati…

Recall number

Z-0959-2019

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems Usa Com

Sold / distributed

US Nationwide Distribution in the states of IN, OH, IL, SC

Why it was 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.

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

What was recalled

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.