FDA-Device2018-11-14Class II
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Medtronic Navigation, Inc.-Littleton
Hazard
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
Sold states
Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KOREA, REPUBLIC OF LUXEMBOURG MARTINIQUE MEXICO NETHERLANDS NEW ZEALAND POLAND PORTUGAL PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED ARAB EMIRATES UNITED KINGDOM
Affected count
641 units
Manufactured in
300 Foster St, Littleton, MA, United States
Products
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0404-2019Don't want to check this manually?
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