Recall Z-0554-2021— Shimadzu Medical Systems

Name: FDA recall Z-0554-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-18

Class II · Ongoing

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2020-11-18. It names one FDA 510(k) clearance: K062360. Product: Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.. Reason: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Ongoing
Initiated: 2020-11-18
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, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

Reason for recall

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

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