Recall Z-0197-2019— Shimadzu Medical Systems Usa Com

Name: FDA recall Z-0197-2019
Creator: U.S. Food and Drug Administration
Published: 2018-06-15

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems Usa Com, initiated 2018-06-15, terminated 2021-04-28. It names one FDA 510(k) clearance: K123508. Product: TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.. Reason: Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel..

Recalling firm: Shimadzu Medical Systems Usa Com
Classification: Class II
Status: Terminated
Initiated: 2018-06-15
Terminated: 2021-04-28
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123508 — TRINIASShimadzu Corporation·cleared 2014-02-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

Reason for recall

Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.

Data sourced from openFDA. This site is unofficial and independent of the FDA.