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Medtronic Navigation, Inc.-Littleton recalls Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm
Recalled October 19, 2016 · FDA recall Z-0070-2017 · Medtronic Navigation, Inc.-Littleton
Hazard
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images · FDA Class II
Units
14 units
Sold at
Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
Description
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Product
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Manufacturer(s)
Medtronic Navigation, Inc.-Littleton
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →