Shimadzu Medical Systems Usa Com: Medical Device Recall in 2019 - (Recall #: Z-0864-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 14, 2019

Date Posted: February 27, 2019

Recall Number: Z-0864-2019

Event ID: 82002

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.

Status: Terminated

Product Quantity: 13 units

Code Information:

Serial Numbers: 41B247746001, 41B24774C001, 41E58C757001, 41E58C765001, 41E58C766001, 41E58C769001, 41E58C76B001, 41E58C773001, 41E58C775001, 41E58C776001, 41E58C777001, 41E58C977001, 41EFCD77C001

Distribution Pattern:

FL, MT, CT, OH, IL, TX, MS, LA, SC

Voluntary or Mandated:

Voluntary: Firm initiated