Medtronic Navigation O-arm O2 Surgical Imaging System recall
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a…
Why was Medtronic Navigation O-arm O2 Surgical Imaging System recalled?
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Quantity
- 14 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
- Recall date
- October 19, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)