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All product recalls associated with Medtronic Navigation, Inc.-Boxborough.
Total Recalls
19
Past Year
1
Class I (Serious)
0
Most Recent
May 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.