Torrance, CA, United States

Shimadzu Medical Systems Usa Com recalls

4 recalls recorded since 2018, most recently on 14 January 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls4

Ongoing (FDA)0

Terminated or completed4

Class I (FDA)0

Recall started: 14 January 2019
Terminated: 7 June 2024
Reason: 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.
Distribution: US Nationwide Distribution in the states of IN, OH, IL, SC
Initiated: Voluntary: Firm initiated
Recall number: Z-0959-2019

BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium

Recall started: 14 January 2019
Terminated: 30 April 2021
Reason: 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.
Distribution: FL, MT, CT, OH, IL, TX, MS, LA, SC
Initiated: Voluntary: Firm initiated
Recall number: Z-0864-2019

TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole b

Recall started: 14 January 2019
Terminated: 13 April 2023
Reason: In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-1039-2019

SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpa

Recall started: 15 June 2018
Terminated: 28 April 2021
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.
Distribution: Domestic: LA
Initiated: Voluntary: Firm initiated
Recall number: Z-0197-2019

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

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.