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Medtronic Navigation, Inc. recalls Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Recalled March 20, 2013 · FDA recall Z-0926-2013 · Medtronic Navigation
Hazard
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction · FDA Class II
Units
463 units
Sold at
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.
Description
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Product
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →