Medtronic Navigation, Inc.-Littleton recalls Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Sur…

Recall date

September 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0070-2017

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.-Littleton

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland

Why it was recalled

O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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