Z-0864-2019Class II

TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular...

Name: Z-0864-2019 TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular...
Creator: Shimadzu Medical Systems Usa Com
Published: 2019-01-14
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2019-01-14 / Terminated / root cause: software

FDA source

Shimadzu Medical Systems Usa Com began a recall of TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography... on 2019-01-14. FDA classified it as Class II and gives the reason as "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...". 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-0864-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-14
Posted: 2019-02-21
Terminated: 2021-04-30
Recalling firm: Shimadzu Medical Systems
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
Root cause tag: software
FDA 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 in commerce: 13 units
Distribution: FL, MT, CT, OH, IL, TX, MS, LA, SC
Product codes and lots: Serial Numbers: 41B247746001, 41B24774C001, 41E58C757001, 41E58C765001, 41E58C766001, 41E58C769001, 41E58C76B001, 41E58C773001, 41E58C775001, 41E58C776001, 41E58C777001, 41E58C977001, 41EFCD77C001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0864-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0864-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-21

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)