Shimadzu Medical Systems Usa Com: Medical Device Recall in 2018 - (Recall #: Z-0197-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 15, 2018

Date Posted: October 31, 2018

Recall Number: Z-0197-2019

Event ID: 81080

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1

Code Information:

Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001

Distribution Pattern:

Domestic: LA

Voluntary or Mandated:

Voluntary: Firm initiated