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Medtronic Navigation, Inc. recalls Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system de
Recalled March 16, 2016 · FDA recall Z-1088-2016 · Medtronic Navigation
Hazard
Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality · FDA Class II
Units
1 unit
Sold at
Worldwide Distribution to Austria only.
Description
Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality
Product
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging 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.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →