Z-2591-2020Class II

Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f -

Name: Z-2591-2020 Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f -
Creator: Shimadzu Medical Systems
Published: 2019-11-04
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2019-11-04 / Completed / root cause: design

FDA source

Shimadzu Medical Systems began a recall of Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional... on 2019-11-04. FDA classified it as Class II and gives the reason as "The DAP meters were found to be outside of tolerance". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2591-2020
Classification: Class II
Status: Completed
Initiated: 2019-11-04
Posted: 2020-07-14
Recalling firm: Shimadzu Medical Systems
Product: Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The DAP meters were found to be outside of tolerance.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued a Field Safety Notice dated 11/5/2019 via email on 11/4/2019 describing the issue in "Digital Angiography System Trinias." The local representative was going to correct the device at the consignee locations.
Quantity in commerce: 3 devices
Distribution: US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Product codes and lots: Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2591-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2591-2020	Class II	Completed	Voluntary: Firm initiated	2020-07-22	2020-07-14

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)