Device 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
Z-0070-2017
Product summary
- Event
- Event 75279
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-0070-2017
Official wording
Reason: O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
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
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
Derived failure modes
-
Unknown
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images