Medtronic Navigation, Inc.-Boxborough FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to MDT.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.Class IIMay 19, 2026Potential for image artifacts caused by an anomaly in the O-	Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.	Class IIDevices	May 19, 2026
O-arm O2 Imaging System. Mobile X-Ray System.Class IIMay 27, 2025A mechanical component that supports the O2 gantry to the su	A mechanical component that supports the O2 gantry to the support structure in affected devices may have been	Class IIDevices	May 27, 2025