O-arm O2 Imaging System. Mobile X-Ray System.

Recall Insight

This FDA Devices action (record #Z-2101-2025) was formally reported on July 16, 2025, with the manufacturer initiating the action on May 27, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Navigation, Inc.-Boxborough is listed as the recalling firm, operating out of Boxborough, MA. Federal records indicate 3 units units are affected.

The documented reason for this recall is: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of IN, MN, MS.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.