Z-0197-2019Class II

TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography...

Name: Z-0197-2019 TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography...
Creator: Shimadzu Medical Systems Usa Com
Published: 2018-06-15
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2018-06-15 / Terminated / root cause: software

FDA source

Shimadzu Medical Systems Usa Com began a recall of TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography... on 2018-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0197-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-15
Posted: 2018-10-19
Terminated: 2021-04-28
Recalling firm: Shimadzu Medical Systems
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA 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, there is a possibility the C-arm will come into contact with a patient or healthcare personnel. The specific conditions are as follows: (1) The table top is positioned at head side so that the C-arm safety interlock is active. (2) If operator performs a parking operation and presses a direct memory switch at the same time, the the software runs abnormally, and the C-arm does not movebecause the safety interlock is active (1). (3) If the operator then moves the table top to foot side, the C-arm safety interlock is cancelled. (4) While the C-arm safety interlock is cancelled due to the actions performed in (3), the C-arm starts moving without the operators control. Therefore, the firm will implement a voluntary recall/field corrective action to revise the software, thereby fixing the problem. This Field Safety Notice is intended to inform the customer about: - the description of the issue - the actions planned by Shimadzu to correct the issue - the actions that should be taken by the customer How to identify the affected products: The Shimadzu Digital Angiographic System Trinias; Serial Number 41E58C977001 Please contact the local Shimadzu representative or contact Shimadzu National Technical Support. Corrective action plan by Shimadzu: After the software defect has been corrected and the correction safety and efficacy have been verified through our verifi
Quantity in commerce: 1
Distribution: Domestic: LA
Product codes and lots: Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0197-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-19

Product code OWB

K123508Class IITriniasShimadzu Corporation / cleared 2014-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)