FDA-Device2012-06-27Class II
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Medtronic Navigation, Inc.
Hazard
Software Version 3.1.1 does not meet navigational accuracy.
Sold states
Nationwide Distribution including the states of CO, IN, and MN.
Affected count
3 units
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2012Don't want to check this manually?
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