Reported Mar 14, 2018 · Terminated
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a…
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 St · Littleton, MA · 01460-2017
Is this the product you have?
- O-arm¿ O2 interventional fluoroscopic x-ray system
- Catalog NumberB1-700-02000 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
- Lot codes and dates
- Serial Numbers
513 of 513 codes
1065RC0875C0876C0877C0878C0879C0930C0931C0932C0933C0934C0935C0936C0962C0963C0964C0965C0966C0967C0973C0974C0977C0978C0981C0982C0985C0986RC0989C0990C0993C0994RC0997C0998C1001C1002C1007C1010C1011C1013C1015C1016C1021C1022C1025C1027C1029C1031C1033C1035C1036C1037C1038C1040C1042C1043C1044C1045C1046C1047C1050
- Serial Numbers
- Amount recalled
- 449
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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