Recall Z-0070-2017— Medtronic Navigation, Inc.-Littleton
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc.-Littleton, initiated 2016-09-22, terminated 2017-05-12. It names one FDA 510(k) clearance: K151000. 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. Reason: O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images.
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-22
- Terminated
- 2017-05-12
- Firm location
- Littleton, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.