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Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
Recalled July 16, 2025 · FDA recall Z-2101-2025 · Medtronic Navigation, Inc.-Boxborough
Hazard
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the states of IN, MN, MS.
Description
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Product
O-arm O2 Imaging System. Mobile X-Ray System.
Manufacturer(s)
Medtronic Navigation, Inc.-Boxborough
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →