Medtronic Navigation, Inc.-Littleton 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
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patientsClass IIApr 26, 2024Potential for an electrical component of the O-arm" O2 Imagi	Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can c	Class IIDevices	Apr 26, 2024
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatricClass IIJul 25, 2023Ground cable installed incorrectly.	Ground cable installed incorrectly.	Class IIDevices	Jul 25, 2023