FDA-Device2018-03-14Class II
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V R
Medtronic Navigation, Inc.-Littleton
Hazard
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.
Sold states
Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Puerto Rico. Distributed in Algeria, Australia, Chile, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Jordan, Lebanon, Sri Lanka, New Zealand, Nicaragua, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.
Affected count
253
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V RWK, Product Number: Bl70000028230R (UDI: 00643169354081) Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2018Don't want to check this manually?
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