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.
Published March 6, 2019 · Recall initiated: January 14, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Shimadzu Medical Systems Usa Com
- Distributor
- US Nationwide Distribution in the states of IN, OH, IL, SC
- Lot
- Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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