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Recall Observatory FDA recall evidence

Device product

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.

Z-0197-2019

June 15, 2018

Class II

Product summary

Firm
Shimadzu Medical Systems Usa Com
Event
Event 81080
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0197-2019

Official wording

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.

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

Distribution pattern: Domestic: LA

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue