FDA-Device2012-08-29Class II
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Medtronic Navigation, Inc.
Hazard
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Sold states
Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
Affected count
17 units
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2012Don't want to check this manually?
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