FDA-Device2020-01-08Class II
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Medtronic Navigation, Inc.-Littleton
Hazard
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
Sold states
US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM
Affected count
90
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2020Don't want to check this manually?
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