Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

Recall Insight

This FDA Devices action (record #Z-0926-2013) was formally reported on March 20, 2013, with the manufacturer initiating the action on January 31, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Navigation, Inc. is listed as the recalling firm, operating out of Littleton, MA. Federal records indicate 463 units units are affected.

The documented reason for this recall is: Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, …. 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 13 years 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.