O-arm O2Recalls & reported problems across all models

We found 2 models of O-arm O2 by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between May 21, 2024 and May 28, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (14 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

O-arm O2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 19, 2026Open, Classified

   Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

   Z-2451-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported O-arm O2 problems

O-arm O2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• O-arm O2 BI70002000

  Interventional fluoroscopic x-ray system
  1 recall33 reports
• O-arm O2 BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  6 reports

Recent O-arm O2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SITE WAS SEEING ARTIFACT IN THEIR 2D AND 3D SCANS. SITE REBOOTED AND TOOK ADDITIONAL SCANS AND NO LONGER SAW THE ARTIFACT. UNKNOWN WHEN RAD GAIN CALIBRATIONS COMPLETED LAST. PATIENT PRESENCE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316016 ↗
• MalfunctionMay 28, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS A LARGE WHITE ARTIFACT ON 3D IMAGING. AND WAS UNSURE IF THIS WAS ALSO PRESENT ON 2D IMAGES. ADDITIONAL INFORMATION STATING THAT "THE PROCEDURE BEING PERFORMED WHEN THE EVENT OCCURRED WAS A POSTERIOR CERVICAL FUSION. THE PATIENT OUTCOME WAS UNIMPACTED BY THE EVENT. THE EVENT CAUSED ABOUT A 15-MINUTE DELAY IN THE CASE WHILE THEY SWITCHED TO A DIFFERENT IMAGING SYSTEM AND PERFORMED ANOTHER SCAN. THE ISSUE OCCURRED INTRA-OP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315859 ↗
• MalfunctionMay 19, 2026Radiation Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT REPORT A SECOND OCCURRENCE OF AN IMAGING ISSUE FIRST REPORTED ON ANOTHER CASE. FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE ISSUE HAD BEEN TRACED BACK TO A BAD ASIC ON THE DETECTOR PANEL. THERE WAS A PATIENT PRESENT. 2025-NOV-14 E1 (REP): ADDITIONAL INFORMATION RECEIVED. IT WAS OCCURRED OUTSIDE OF PROCEDURE AND OCCURRED PRE OPERATIVELY. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216690 ↗
• 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 ↗
• MalfunctionJan 28, 2026Mechanical Problem; Unintended System Motion; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED REGARDING DRIVE ISSUES THAT THE SYSTEM WAS NOT DRIVING AS INTENDED WITH THE CLUTCH MOTOR ENGAGED. IMAGING SYSTEM PULLS TO THE RIGHT AND GIVES RESISTANCE AND PULLING IT BACK CAUSES IT TO MOVE BACK VERY FAST. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196901 ↗
• MalfunctionNov 28, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Device Fell; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Device Fell

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED REGARDING LOOSE GANTRY PIECE AND THERE WAS A PIECE OF THE INNER GANTRY THAT HAS FALLEN OUT OF THE SYSTEM. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669281 ↗
• 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 ↗
• MalfunctionOct 23, 2025Failure to Advance; Positioning Problem; Application Program Freezes or Fails to Launch; Failure to Advance; Positioning Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS UNABLE TO DOCK. SITE ATTEMPTED TO INVALIDATE HOME, HOWEVER THE GANTRY WOULD NOT PROCEED PAST THE LEFT TILTED POSITION. REPRESENTATIVE CONFIRMED WITH THE SITE THAT HE WAS ABLE TO MOVE THE GANTRY IN DIFFERENT POSITIONS, HOWEVER HE ALSO REPORTED THAT THE "DOOR OPEN" BUTTON ON THE PENDANT WAS UNRESPONSIVE. IMAGING SYSTEM FULLY EXTENDED AND WAS NOT ABLE TO BRING IT BACK INTO THE HOME POSITION. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364750 ↗
• 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 ↗
• MalfunctionJul 28, 2025Failure to Advance; Application Program Freezes or Fails to Launch; Failure to Advance; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS STUCK IN INITIALIZING UPON BOOT UP, AFTER REBOOTING THE ISSUE RESOLVED AND THEY PROCEEDED TO USE THE SYSTEM. LATER DURING THE CASE, THE GANTRY WOULD THEN NOT OPEN AND WAS STUCK AROUND THE PATIENT.  PATIENT WAS PRESENT. THERE WAS LESS THAN ONE HOUR OF SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630336 ↗
• MalfunctionJul 25, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ARM WON'T OPEN. REPRESENTATIVE ATTEMPTED TO MANUALLY OPEN THE ARM WITH THE CRANK BUT THE DOOR WOULD NOT OPEN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606271 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE UNIT WAS HAVING DIFFICULTY OPENING AND CLOSING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385153 ↗
• MalfunctionJul 2, 2025Mechanical Problem; Failure to Advance; Noise, Audible; Mechanical Problem; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE DURING A CASE, THE GANTRY DOORS WERE MAKING A LOUD NOISE AND GOT STUCK AROUND THE PATIENT. SITE HAD TO MANUALLY OPEN THEM. THE DOOR WOULD NOT OPEN. MANUFACTURING REPRESENTATIVE(REP) WALKED THEM THROUGH THE YELLOW BUTTON EMERGENCY OVERRIDE. REP WAS UNKNOWN THROUGH DOOR OPENING PROCEDURE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384510 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT GANTRY WILL NOT OPEN. AS A TROUBLESHOOTING STEP, REPRESENTATIVE MANUALLY REHOMED ROTOR, AND INVALIDATED HOME AND IT RESOLVED THE ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383168 ↗

Other Medtronic Navigation, Inc. products

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