Company: Shimadzu Medical Systems
Date of Enforcement Report: 12/16/2020
Class II

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.

Recall Number: Z-0554-2021

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/MANUFACTURER

Shimadzu Medical Systems on 11/18/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

7 units

DISTRIBUTION

U.S. Nationwide