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Recall Observatory FDA recall evidence

Device 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.

Z-0554-2021

November 18, 2020

Class II

Product summary

Firm
Shimadzu Medical Systems
Event
Event 86846
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-0554-2021

Official wording

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.

Code information: Serial Numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901

Distribution pattern: US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software for the celling arm of the X-Ray System . This software issue