O-ARM® BI70002000 (UDI 00763000068097)Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 00763000068097), received between Sep 28, 2018 and May 26, 2026 — classified as 2 injuries, 285 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (131 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 9, 2019Terminated

   Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

   Z-1995-2020 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Noise, Audible; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE 2D LONG FILM SPIN CANNOT BE TAKEN. AFTER REBOOT, SYSTEM WAS CONSTANTLY BEEPING WHEN ON. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278446 ↗
• MalfunctionMar 20, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM "LOCKED UP" OVER A PATIENT AND HAD TO BE REBOOTED TO OPEN. 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 24652926 ↗
• MalfunctionJan 30, 2026Failure to Advance; Device Fell

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS NOT OPENING SMOOTHLY. THE SITE THOUGHT THERE WERE BEADS OR SOMETHING THAT FELL OUT OF THE GANTRY AS WELL. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219502 ↗
• MalfunctionJan 21, 2026Mechanical Problem; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR WOULD NOT OPEN WHEN IT WAS AROUND THE PATIENT. LOUD THUMPING NOISE BY THE DOOR WHEN PRESSING OPEN BUTTON. YELLOW BUTTON DID NOT WORK. MANUALLY CRANKING DOOR OPEN WAS SUCCESSFUL. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN ONE HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130210 ↗
• MalfunctionDec 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE CRANIAL IMAGES APPEARED TO BE DISTORTED AND "SQUISHED" ON THE RIGHT ANTERIOR SIDE. SITE WERE ABLE TO USE THE IMAGES TO PROCEED WITH THE CASE. 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 23825012 ↗
• MalfunctionAug 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED "NO IMPACT ON PATIENT OUTCOME".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836531 ↗
• MalfunctionJul 8, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT WHEN BOOTING UP THE SYSTEM, THE PENDANT WAS DISPLAYING THE COLLIMATION ICON ON THE SCREEN. CLINICAL SPECIALIST (CS) WENT TO OPEN THE COLLIMATION BUT IT WOULDN'T OPEN SO CS REBOOTED SYSTEM. UPON BOOT-UP, CS WAS RECEIVING AN ERROR "ERROR INITIALIZING COLLIMATOR." THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435114 ↗
• MalfunctionJul 7, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR OF THE IMAGING SYSTEM WAS CLOSED AROUND A PATIENT AND WOULD NOT OPEN DUE TO A MISALIGNED COVER. PATIENT PRESENT AT TIME OF EVENT. NO FURTHER INFORMATION AVAILABLE AT TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413537 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A CASE THE SYSTEM GANTRY WOULD NOT FULLY CLOSE AND WHEN TRYING TO OPEN IT BACK UP, WOULD ALSO NOT OPEN. THE REPRESENTATIVE REPORTED THE SITE PERFORMED THE MANUAL OPENING PROCESS TO GET TO THE PATIENT. SITE ABORTED SYSTEM FROM CASE. SITE REPORTED 25 MINUTES OF SURGICAL DELAY. PATIENT WAS PRESENT AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385465 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS NOT OPENING OR CLOSING. THERE WAS UNKNOWN PATIENT PRESENT DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383706 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Failure to Advance; Mechanical Problem; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A PENDING SURGICAL PROCEDURE. IT WAS REPORTED THAT THE MANUAL DOOR OPEN PROCEDURE FAILED AS THE GANTRY WOULD NOT OPEN WHILE POSITIONED AROUND THE PATIENT. THE SITE ATTEMPTED TO USE THE EMERGENCY DOOR BUTTON, BUT IT DID NOT WORK. THEY THEN TRIED THE MANUAL DOOR OPEN PROCEDURE. ALTHOUGH THE INDICATOR TURNED ORANGE, THE T-HANDLE WOULD NOT SEAT PROPERLY. WHEN THEY MANAGED TO SEAT IT CORRECTLY AND BEGAN RATCHETING THE HANDLE, THEY FELT IMMEDIATE RESISTANCE AND CHOSE NOT TO PROCEED. THE IMAGING SYSTEM WAS MOVED TOWARD THE BASE OF THE PATIENT BED, AND THE SURGERY CONTINUED. THE LENGTH OF THE SURGICAL DELAY WAS PENDING. THE PATIENT OUTCOME WAS PENDING. ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE BEING PERFORMED WAS A SACROILIAC AND THORACOLUMBAR PROCEDURE AND THERE WAS A SURGICAL DELAY AS THE SITE WAS NEVER ABLE TO GET THE IMAGING SYSTEM OPEN SO THEY HAD TO IMPROVISE TO GET THE PATIENT OFF THE TABLE AND DISMANTLED THE SURGICAL BED TO GET THE IMAGING SYSTEM OUT. SURGICAL DELAY AMOUNT UNKNOWN. THE SCREWS THAT WERE PLACED WERE UNABLE TO BE CHECKED AND THE ISSUE OCCURRED INTRA-OPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 22373378 ↗
• MalfunctionJul 1, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR IS NOT OPENING ON THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372766 ↗
• MalfunctionJul 1, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT THE SITE REPORTED THAT THEY HAD ISSUES OPENING AND CLOSING THE GANTRY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368830 ↗
• MalfunctionJun 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 GANTRY WOULD NOT OPEN AND THEY HAD TO MANUALLY OPEN IT. THE SITE HAD TO MANUALLY OPEN THE GANTRY THREE TIMES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326684 ↗
• MalfunctionJun 25, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT OPEN AND THE SITE HAD TO MANUALLY OPEN THE GANTRY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326544 ↗
• MalfunctionJun 13, 2025Radiation Output Failure; Application Program Freezes or Fails to Launch; Radiation Output Failure; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING A CASE WITH THE SYSTEM, THE HAND SWITCH APPEARED TO BE UNRESPONSIVE AND THE SYSTEM COULD NOT EXPOSE ON THE 2D PAGE WHILE THE PATIENT WAS IN THE IMAGING SYSTEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206432 ↗
• MalfunctionJun 5, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT PENDANT (BUTTONS) WAS EXTREMELY HARD TO PRESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151258 ↗
• MalfunctionMay 30, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE TAKING SCOUT SHOTS THE SYSTEM WOULD NOT TAKE AN IMAGE. SYSTEM WAS REBOOTED AND PERFORMED AS INTENDED. 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 22111876 ↗
• MalfunctionMay 29, 2025Unintended System Motion; Unintended System Motion

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM ACCELERATED UNPREDICTABLY WHEN DRIVING THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105895 ↗
• MalfunctionMay 19, 2025Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AFTER DOCKING THE GANTRY, A COLLISION ZONE ERROR APPEARED ON THE PENDANT. THE REPRESENTATIVE CHECKED AGAIN ABOUT 15 MINUTES LATER AND THE ERROR WAS CLEARED. 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 22045184 ↗
• MalfunctionMay 14, 2025Mechanical Problem; Application Program Freezes or Fails to Launch; Mechanical Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO EXTEND THE GANTRY (NO WAG OR UP/DOWN.) REBOOTED SYSTEM TWICE AND FUNCTIONALITY RETURNED AFTER PERFORMING SPIN BUT PROCEEDED WITH CASE BY GOING TO FLUORO. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME AND MEDTRONIC WAS IMAGING ABORTED. THIS ISSUE WAS 2ND OCCURRENCE. ADDITIONAL INFORMATION STATING THAT THE PENDANT BUTTONS WERE FUNCTIONING INTERMITTENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016303 ↗
• MalfunctionMay 6, 2025Application Program Problem; Output Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Output 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 PENDANT SAID "SYSTEM BOOTING PLEASE WAIT". CLINICAL CONSULTANT REBOOTED THE SYSTEM, BUT THE PENDANT SCREEN REMAINED BLACK AND WOULD NOT POWER ON, BUT THE IMAGING ACQUISITION SYSTEM BLUE POWER LED WAS FLASHING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967237 ↗
• MalfunctionApr 29, 2025Radiation Output Failure; Radiation Output Failure

  BOTH MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923895 ↗
• MalfunctionMar 24, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  ADD INFO RECEIVED- THIS WAS RESOLVED OVER THE PHONE. GAIN CAL HAD TO BE COMPLETED AND IT RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21674723 ↗
• MalfunctionMar 20, 2025Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED REGARDING NON-NAVIGATED SPIN THAT THE SYSTEM WOULD NOT TAKE A NAVIGATED SPIN. REPRESENTATIVE REPORTED ALL 3 OF THE BOXES ON THE IMAGE ACQUISITION SCREEN WERE GREEN THROUGHOUT THE ENTIRE SPIN. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650806 ↗