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.
Enforcement
- Recall Number
- Z-0959-2019
- Event ID
- 81981
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shimadzu Medical Systems Usa Com
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 6, 2019
- Initiation Date
- January 14, 2019
- Classification Date
- February 26, 2019
- Termination Date
- June 7, 2024
- Address
- 20101 S Vermont Ave, Torrance, CA, 90502-1328, United States
Description
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.
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.
Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302
US Nationwide Distribution in the states of IN, OH, IL, SC
8 units