FDAFDA · Food and drugs·Recall number Z-0070-2017
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
Published October 19, 2016 · Recall initiated: September 22, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Distributor
- Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
- Lot
- Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930 C0981 C0986 C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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