Z-0070-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- September 22, 2016
- Termination Date
- May 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
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
Reason for Recall
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
Code Information
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