FDA-Device2025-07-16Class II
O-arm O2 Imaging System. Mobile X-Ray System.
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.
Sold states
US Nationwide distribution in the states of IN, MN, MS.
Affected count
3 units
Manufactured in
200 Beaver Brook Road, N/A, Boxborough, MA, United States
Products
O-arm O2 Imaging System. Mobile X-Ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2101-2025Don't want to check this manually?
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