Recall Z-0070-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Littleton
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
| Date | Oct 11, 2016 (initiated Sep 22, 2016) |
| Status | Terminated |
| Reason | O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images |
| Root cause | Software design |
| Action | Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016. |
| Quantity | 14 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151000 | O-Arm O2 Imaging System Medtronic, Inc., Aug 6, 2015 |