Recall Z-0959-2019— Shimadzu Medical Systems Usa Com

Name: FDA recall Z-0959-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-14

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems Usa Com, initiated 2019-01-14, terminated 2024-06-07. It names one FDA 510(k) clearance: K062360. Product: 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. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.. 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..

Recalling firm: Shimadzu Medical Systems Usa Com
Classification: Class II
Status: Terminated
Initiated: 2019-01-14
Terminated: 2024-06-07
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K062360 — BRANSIST SAFIREShimadzu Corp.·cleared 2006-10-05

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

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. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.

Reason for recall

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.

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