medical Class II Updated 2020-12-16

Shimadzu Medical Systems recalls Bransist Safire, Digital Angiography System containing a MS-

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901
View official government recall

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