Shimadzu Medical Systems: Medical Device Recall in 2020 - (Recall #: Z-2591-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 4, 2019

Date Posted: July 22, 2020

Recall Number: Z-2591-2020

Event ID: 85416

Reason for Recall:

The DAP meters were found to be outside of tolerance.

Status: Completed

Product Quantity: 3 devices

Code Information:

Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.

Distribution Pattern:

US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated