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Medtronic Navigation, Inc.-Littleton recalls O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients
Recalled June 12, 2024 · FDA recall Z-2026-2024 · Medtronic Navigation, Inc.-Littleton
Hazard
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance. · FDA Class II
Units
20 units
Sold at
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, MN, PR, TX, WI and the countries of Bangladesh, Canada, Costa Rica, India, Mexico, Panama, Philippines.
Description
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
Product
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Manufacturer(s)
Medtronic Navigation, Inc.-Littleton
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →