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