O-ARM® BI70000028120 (UDI 00643169353428)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,343 adverse event reports that list this exact device (DI 00643169353428), received between Jan 5, 2017 and May 20, 2026 — classified as 9 injuries, 1,334 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (409 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 25 most recent of 1,343 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Failure to Advance; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED REGARDING UNABLE TO MOVE GANTRY THAT THE SYSTEM WAS NOT RESPONDING TO COMMANDS TO MOVE OR OPEN. SYSTEM WAS DOWN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228349 ↗
• MalfunctionJun 30, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT FULLY CLOSE OR OPEN. THERE WAS NO PATIENT PRESENT DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360055 ↗
• MalfunctionJun 27, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT OPEN. THEY MANUALLY OPENED THE GANTRY. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT IMAGES WERE NOT TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344040 ↗
• MalfunctionMay 21, 2025Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 SYSTEM WAS STUCK SHOWING COLLIMATOR INITIALIZING. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058624 ↗
• MalfunctionMay 10, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A FRAME RATE ERROR AND EVENTUALLY LOST COMMUNICATION WITH THE MVS (MOBILE VIEWING SYSTEM). PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999584 ↗
• MalfunctionMay 2, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO EXPOSE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947525 ↗
• MalfunctionApr 2, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT TAKING 2D OR 3D SCANS. SITE WAS USING HAND SWITCH AT THE TIME, DID NOT TEST FOOTSWITCH. REPORTS NOT SEEING ANY ERROR ON SYSTEM. SITE REBOOTED WITH NO CHANGE. ABORTED IMAGING SYSTEM USE. PATIENT WAS PRESENT, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751630 ↗
• MalfunctionMar 21, 2025Failure to Charge; Adverse Event Without Identified Device or Use Problem; Failure to Charge; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING PLANNED MAINTENANCE (PM) IT WAS DISCOVERED THAT THE BATTERY CHARGING BOARD ON THIS SYSTEM WAS BAD AND WAS NOT PROPERLY CHARGING THE BATTERIES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663938 ↗
• MalfunctionFeb 19, 2025Positioning Problem; Noise, Audible; Application Program Freezes or Fails to Launch; Positioning Problem; Noise, Audible; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT PERFORMING A SPIN DURING A CASE. THE SITE PERFORMED MULTIPLE REBOOTS AND WAS ABLE TO GET THE SYSTEM TO PERFORM SPINS INTERMITTENTLY. THE SYSTEM ALSO HAD A SCREECHING SOUND WHEN MOVING THE GANTRY. ADDITIONALLY, THE SITE COULD NOT GET THE GANTRY TO LOWER. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. 2023-FEB-02 (REP) E1: ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE OCCURRED INTRAOPERATIVELY AND THERE WAS A 5 MINUTE DELAY DUE TO REBOOT ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413248 ↗
• MalfunctionFeb 19, 2025Mechanical Problem; Radiation Output Failure; Mechanical Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE HANDSWITCH WOULD NOT TAKE 2D IMAGES BUT WILL TAKE 3D IMAGES ON THE HANDSWITCH. BOTH IMAGES COULD BE TAKEN USING THE FOOTSWITCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413058 ↗
• MalfunctionFeb 18, 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 FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AFTER SUCCESSFUL ANTEROPOSTERIOR FLUORO IMAGES, THEY PROCEEDED TO TOOK LATERAL IMAGE AND THE SYSTEM WOULD NOT SPIN. REPRESENTATIVE TRIED THE HAND SWITCH AND FOOT PEDAL AND REBOOT OF THE SYSTEM WITH NO RESOLUTION. THE SYSTEM WAS STUCK IN INITIALIZING AFTER THE REBOOT. THIS WAS OCCURRED INTRA OPERATIVELY. THERE WAS A REPORTED DELAY OF LESS THAN 1 HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397053 ↗
• MalfunctionJan 31, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM FROZE TWICE DURING THE CASE. BOTH TIMES THE MOUSE WOULD NOT MOVE, NOTHING COULD BE SELECTED ON THE MOBILE VIEWING STATION (MVS), AND THEY WERE UNABLE TO EXPOSE. THE SITE REBOOTED THE SYSTEM TWICE IN ORDER TO USE IT. NO IMPACT ON PATIENT OUTCOME. THERE WAS LESS THAN 1 HOUR DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282861 ↗
• MalfunctionJan 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGICAL TEAM WENT TO DO A 3D SPIN, THEY ALIGNED AP AND LATERAL SCANS AND MADE SURE THERE WERE ALL THREE GREEN BARS OF COMMUNICATION. THE SYSTEM WAS UNABLE TO SPIN AND PROMPTED AN ERROR MESSAGE: "3D SPIN UNAVAILABLE, NAVIGATION SYSTEM DETECTED BUT NOT READY" MESSAGE. THE MEDTRONIC REPRESENTATIVE REBOOTED THE BOTH SYSTEMS AND THEN THE SITE WAS ABLE TO TAKE A 3D SPIN. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236030 ↗
• MalfunctionJan 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WOULDN'T EXPOSE. SOMETIMES THE SITE WOULD REBOOT THE SYSTEM, AND EVENTUALLY IT WOULD WORK, BUT NOT ALWAYS. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233606 ↗
• MalfunctionNov 13, 2024Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WOULD NOT TAKE A 2D OR 3D SCAN. THE SITE REBOOTED THE UNIT AND AFTER REBOOTS, THEY WERE ABLE TO SCAN, BUT IT WAS REPORTED THAT THIS RESULTED IN "A BIG DELAY TO THE CASE." THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675508 ↗
• MalfunctionNov 13, 2024Application Program Freezes or Fails to Launch; 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 IMAGING SYSTEM WAS REFUSING TO START FLUORO. THE SITE THEN REBOOTED SYSTEM AND THEY WERE ABLE TO TAKE SHOTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674650 ↗
• MalfunctionNov 13, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS AROUND A PATIENT AND APPEARED TO BE FULLY READY TO EXPOSE BUT WHEN THE BUTTON WAS PRESSED NOTHING SEEMED TO HAPPEN. THE SITE REBOOTED THE SYSTEM AND THE ISSUE RESOLVED. THIS RESULTED IN A SURGICAL DELAY OF ABOUT 5 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674541 ↗
• MalfunctionNov 13, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO TAKE A SPIN. MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED. PATIENT IMPACT HAS NOT BEEN REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED. THIS OCCURRED DURING A MULTI-LEVEL POSTERIOR SPINAL FUSION. THERE WAS ABOUT A 15 MINUTE DELAY AND THERE WAS NO IMPACT ON PATIENT OUTCOME. THE SYSTEM WAS TROUBLESHOOTED AND ULTIMATELY REBOOTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE SURGERY WAS NOT ABORTED. THE SYSTEM WAS RESTARTED AND THE SITE WAS ABLE TO CONTINUE THE SURGERY AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674074 ↗
• MalfunctionNov 12, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO EXPOSE. THE SITE WAS ABLE TO DO ONE SPIN, THEN THEY WENT TO DO THE SECOND SPIN AND SYSTEM WOULD NOT EXPOSE. THEY REBOOTED AND THE SYSTEM WAS STUCK IN INITIALIZING PLEASE WAIT. THEY REBOOTED THE MOBILE VIEW STATION (MVS) AND THE IMAGE ACQUISITION SYSTEM (IAS) AGAIN, DISCONNECTED AND RECONNECTED THE UMBILICAL THIS TIME AND THE SYSTEM INITIALIZED AND EXPOSED. THERE WAS LESS THAN AN HOUR DELAY IN THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664015 ↗
• MalfunctionNov 12, 2024Noise, Audible; Application Program Freezes or Fails to Launch; Noise, Audible; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS CONTINUOUSLY BEEPING AND COULD NOT TAKE SCOUTS. THE SITE TOOK A SPIN AND THE SPIN WAS FINE. THEY REBOOTED AND A LONG ERROR MESSAGE DISPLAYED ON THE SYSTEM. DELAY AND PATIENT IMPACT INFORMATION WERE NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THE REPORTED ISSUE OCCURRED DURING A LUMBAR FUSION PROCEDURE. THE ISSUE RESULTED IN A PROCEDURE DELAY OF LESS THAN FIVE MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME. THERE WERE NO UNUSED SPINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663780 ↗
• MalfunctionOct 29, 2024Noise, Audible; Radiation Output Failure; Noise, Audible; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS MAKING CLICKING NOISES AND WAS UNABLE TO EXPOSE. SITE REBOOTED A FEW TIMES WITH NO EFFECT. AFTER REMOVING THE SYSTEM FROM THE OR, SITE WAS ABLE TO EXPOSE ONCE BUT THEN THE ISSUE REOCCURRED. THIS ISSUE OCCURRED INTRA OPERATIVELY AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555235 ↗
• MalfunctionOct 24, 2024Mechanical Problem; Arcing; Mechanical Problem; Arcing

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PLUGS ON THE SYSTEM POWER CABLE SPARKED. THE ELECTRICAL HOUSING IS NOW LOOSE AND WIGGLES AROUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520608 ↗
• MalfunctionOct 15, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Radiation Output Problem; Application Program Freezes or Fails to Launch; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Radiation Output Problem; 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 STOPPED SPINNING MID-SPIN DURING A CASE. THE SYSTEM BECAME UNRESPONSIVE, AND THE IMAGING ACQUISITION SYSTEM (IAS) WENT INTO STANDALONE MODE. THE SYSTEM ALSO BECAME UNRESPONSIVE, AND THE GANTRY WOULD NOT OPEN EITHER. THEY REBOOTED THE SYSTEM, WHICH RESOLVED THEIR ISSUE. THEY WERE ABLE TO CONTINUE AND COMPLETE THE CASE. THE DELAY WAS ABOUT 20 MINUTES, AND THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452545 ↗
• MalfunctionOct 4, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS RECEIVING A SYSTEM INTEGRITY ERROR. THEY REBOOTED TWICE BUT STILL RECEIVED THE ERROR MESSAGE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370022 ↗
• MalfunctionOct 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A SPINE SURGERY (C7-T4), THE SURGEON INITIALLY TOOK A THREE DIMENSIONAL (3D) NAVIGATED SPIN. WHILE CHECKING FOR ANATOMICAL ACCURACY, THE SURGEON NOTED THAT ONLY HALF OF THE LEVEL WAS ACCURATE, WHILE THE OTHER HALF WAS INACCURATE. THE SITE DECIDED TO TAKE ANOTHER NAVIGATED SPIN, BUT THE SAME ISSUE PERSISTED. THE MANUFACTURER REPRESENTATIVE (REP) TOOK THE TIME TO READJUST ALL SPHERES ON THE INSTRUMENTS TO ENSURE THEY WERE PROPERLY SEATED ON ALL POSTS. THE SURGEON OBSERVED THAT THE FURTHER THE SURGICAL AREA WAS FROM THE REFERENCE FRAME, THE MORE INACCURATE THE NAVIGATION BECAME. THE SURGEON PROCEEDED TO NAVIGATE FOR THE THREE LEVELS THAT WERE ACCURATE AND USED COMPUTER TOMOGRAPHY (CT) TO FLUOROSCOPY FOR THE REMAINING LEVELS. THE IMAGING AND NAVIGATION WERE ABORTED. THIS ISSUE CAUSED A LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS ABOUT 3 MM OF INACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343908 ↗