O-arm O2 BI70002000 (UDI 00763000616502)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000616502), received between May 21, 2024 and Mar 26, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THERE WAS A NAVIGATION ACCURACY PROBLEM. AFTER TWO SCANS WERE DONE AND TRANSFERRED TO THE NAVIGATION SYSTEM, IT SHOWED INCONSISTENCIES IN ACCURACY. PHYSICIAN CONTINUED PROCEDURE WITH FREEHAND TECHNIQUE, NAVIGATION WAS ABORTED. THE INACCURACY AMOUNT WAS BETWEEN 3-5 MILLIMETERS (MM).  NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS A LESS THAN ONE HOUR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698804 ↗
• MalfunctionFeb 9, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WOULD NOT OPEN FULLY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292961 ↗
• MalfunctionNov 19, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THERE WERE MOVEMENT ISSUES, THE DOOR WOULD NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593285 ↗
• MalfunctionAug 19, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRAOPERATIVELY DURING A POSTERIOR CERVICAL FUSION PROCEDURE. IT WAS REPORTED THAT THE ROTOR ROTATION AND DOOR OPEN WAS NOT RESPONDING. ADDITIONALLY, THE INNER BOTTOM GANTRY COVER AND LEXAN COVER ON THE BOTTOM LEFT WERE BROKEN. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 20-30 MINUTES DUE TO THIS ISSUE BEFORE THE USE OF NAVIGATION WAS ABORTED. HOWEVER, IT WAS NOTED THAT THE MAJORITY OF THE CASE WAS PERFORMED WITH NAVIGATION. THE LAST CONFIRMATION SPIN WAS CANCELLED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842980 ↗
• MalfunctionNov 13, 2024Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem; Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE MOBILE VIEW STATION (MVS) WAS STATING IT "CANNOT ENABLE" AND THAT THE IMAGE WAS ROTATED ON THE MOBILE VIEW STATION (MVS). 2DLF WAS ENABLED, HOWEVER SITE WERE NOT NEEDING 2DLF AND THEY WERE UNABLE TO DESELECT IT. AS A TROUBLESHOOTING STEP SITE CONFIRMED PATIENT WAS NOT ROTATED, ORIENTATION CHECKED AND LOOKED GOOD. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672131 ↗
• MalfunctionMay 21, 2024Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE ATTEMPTING TO CLOSE THE SYSTEM AROUND THE PATIENT, THE GANTRY DOORS WOULD NOT FULLY CLOSE. THERE WAS NO VISIBLE DAMAGE TO THE SYSTEM AND NO OBJECT BLOCKING THE SYSTEM FROM CLOSING. TECHNICAL SERVICES (TS) HAD THE SITE RESTART THE SYSTEM, FULLY OPEN THE GANTRY DOORS, AND THEN ATTEMPT TO CLOSE AGAIN. THE ISSUE REMAINED UNRESOLVED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE THAN 1 HOUR DUE TO THIS ISSUE BEFORE THE USE OF IMAGING WAS ABORTED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19365545 ↗