Recall Z-0959-2019 ยท IZI System, X-Ray, Angiographic
Shimadzu Medical Systems Usa Com
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.
| Date | Jan 14, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 8 units |
| Distribution | US Nationwide Distribution in the states of IN, OH, IL, SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062360 | BRANSIST SAFIRE Shimadzu Corp., Oct 5, 2006 |