PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: December 16, 2020 Initiated: November 18, 2020 #Z-0554-2021

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.

Details

Recalling Firm
Shimadzu Medical Systems
Units Affected
7 units
Distribution
US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
Location
Torrance, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Shimadzu Medical Systems. Units affected: 7 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0554-2021.