Shimadzu Medical Systems Usa Com recalls TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdomin…

Recall date

January 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0864-2019

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems Usa Com

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.