Recall Z-0197-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Shimadzu Medical Systems Usa Com
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
| Date | Oct 19, 2018 (initiated Jun 15, 2018) |
| Status | Terminated |
| Reason | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel. |
| Root cause | Software design |
| Action | On June 15, 2018, the firm sent an URGENT Voluntary Medical Device Recall Notice to its customer via certified mail informing the customer that the Trinias C-arm could unexpectedly move while being moved to the park position and/or when performing specific operations. An investigation has shown that a software defect in the MH300, which is a floormount C-arm tube support of the Trinias biplane system, caused this event under specific conditions described as below. Neither the Trinias single plane system nor the Trinias dual plane system have the software defect. If the incident were to recur, |
| Quantity | 1 |
| Distribution | Domestic: LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |