Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
O-arm¿ O2 interventional fluoroscopic x-ray system Recalled by Medtronic Navigation, Inc.-Littleton Due to During servicing of certain internal components of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc.-Littleton directly.
Affected Products
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
Quantity: 449
Why Was This Recalled?
During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Navigation, Inc.-Littleton
Medtronic Navigation, Inc.-Littleton has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report