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
Reported: October 19, 2016 Initiated: September 22, 2016 #Z-0070-2017
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
Details
- Recalling Firm
- Medtronic Navigation, Inc.-Littleton
- Units Affected
- 14 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medtronic Navigation, Inc.-Littleton. Units affected: 14 units.
Why was this product recalled? ▼
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0070-2017.
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