FDA-Device2013-03-20Class II
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Medtronic Navigation, Inc.
Hazard
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Sold states
Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM.
Affected count
463 units
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2013Don't want to check this manually?
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