Company: Medtronic Navigation Inc.
Date of Enforcement Report 10/12/2016
Class lI:
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 l
Recall Number Z-0070-2017
REASON
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Littleton, MA on 10/11/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Switzerland
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