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Medtronic Navigation, Inc.-Littleton recalls The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric
Recalled August 30, 2023 · FDA recall Z-2449-2023 · Medtronic Navigation, Inc.-Littleton
Hazard
Ground cable installed incorrectly. · FDA Class II
Units
28 units
Sold at
Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KY, MI, MO, NC, NV, OH, TN, UT, VA, & WA. The countries of Canada, Ireland, Poland, Russian Federation, Switzerland, & Viet Nam.
Description
Ground cable installed incorrectly.
Product
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm 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.
Manufacturer(s)
Medtronic Navigation, Inc.-Littleton
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →