Recall Z-0959-2019
Shimadzu Medical Systems Usa Com · initiated January 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302
Reason for recall
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.
FDA-determined cause: Software design
Action taken
Shimadzu sent an Urgent Medical Device Correction Notice letter dated January 2, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letters to the end users explain the problem and a workaround. A service representative will contact the end user to schedule a software update.
Details
- Recall number
- Z-0959-2019
- Initiated
- January 14, 2019
- Terminated
- June 7, 2024
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution in the states of IN, OH, IL, SC
- Recalling firm
- Shimadzu Medical Systems Usa Com, Torrance, CA