Reported Oct 19, 2016 · Terminated
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm…
Medtronic Navigation, Inc.-Littleton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc.-Littleton · 300 Foster Street · Littleton, MA · 01460-2017
Is this the product you have?
- Medtronic Navigation O-arm O2 Surgical
- Imaging System Product Catalog NumberBI-700-02000
- Product UsageThe 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
- Lot codes and dates
Software revisions 4.0.04.0.1 and 4.0.2
- System Serial Numbers
C0930C0981C0986C1113C1069C1050C1208C1043C1144C1163C1145C1162C1002C1074
- Amount recalled
- 14 units
Where it was sold
Why it was recalled
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
This product could cause temporary or reversible health problems — stop using it.
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