Medical Device Recall: O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Medtronic Navigation, Inc.-Littleton · April 26, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
20 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2026-2024
Status: ongoing
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