Recall Z-0864-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Shimadzu Medical Systems Usa Com
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
| Date | Jan 14, 2019 |
| Status | Terminated |
| Reason | Two issues: Event 1: 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. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to exter |
| Root cause | Software design |
| Action | The dealers by email on 01/14/2019 and the end users by mail on 01/15/2019. 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 | 13 units |
| Distribution | FL, MT, CT, OH, IL, TX, MS, LA, SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |