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Medtronic Navigation, Inc. recalls Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The
Recalled June 27, 2012 · FDA recall Z-1849-2012 · Medtronic Navigation
Hazard
Software Version 3.1.1 does not meet navigational accuracy. · FDA Class II
Units
3 units
Sold at
Nationwide Distribution including the states of CO, IN, and MN.
Description
Software Version 3.1.1 does not meet navigational accuracy.
Product
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →