O-ARM® BI70002000 (UDI 00763000074050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00763000074050), received between Mar 15, 2019 and Nov 5, 2025 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (31 reports).

2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 15, 2019Terminated

   Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.

   Z-0767-2020 · Root cause: Device Design · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission 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 MOBILE VIEW STATION (MVS) WOULD OFTEN SHOW "STANDALONE MODE." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478902 ↗
• MalfunctionMar 7, 2025Application 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 IMAGE ACQUISITION SYSTEM (IAS) DID NOT START CORRECTLY. IT WAS NOTED THAT EVERYTHING BOOTED UP, BUT THE SYSTEM/PENDANT ONLY GOT AS FAR AS "INITIALIZATION, PLEASE WAIT..." THE SYSTEM WAS NOT ABLE TO MOVE PAST THAT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21552406 ↗
• MalfunctionFeb 25, 2025Communication or Transmission Problem; Radiation Output Failure; Communication or Transmission Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY DURING A CERVICAL SURGERY. IT WAS REPORTED THAT THE SCAN COULD NOT BE STARTED. FOR 1-2 MINUTES THE SITE CHECKED SYSTEMS AND CONNECTIONS. THE SITE TRIED AGAIN AND THE 3D SCAN STARTED BUT WAS NOT TRANSFERRED TO THE NAVIGATION SYSTEM. MANUAL SENDING WAS ALSO NOT POSSIBLE. THE IMAGING SYSTEM WAS RESTARTED. AFTER THAT, EVERYTHING WENT AS EXPECTED. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459233 ↗
• MalfunctionJan 21, 2025Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch; Adverse Event Without Identified Device or Use 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 SPORADIC AND NO 2D FLUORO IMAGING WAS POSSIBLE. THE GREEN LIGHT WAS FLASHING WHILE PRESSING THE HAND ACTIVATION BUTTON, BUT NO IMAGE APPEARED. IT WAS NOTED THAT THE 3D IMAGING WORKED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE REPORTED ISSUE WAS ABLE TO BE RESOLVED BY USING THE FOOTSWITCH AND SWITCHING BETWEEN 2D AND 3D.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200022 ↗
• MalfunctionOct 11, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS CLOSED, BUT THE SYSTEM SHOWED THAT THE DOOR WAS OPEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426335 ↗
• MalfunctionSep 17, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE TROUBLESHOOTING PERFORMED AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PLUG WAS FIXED TEMPORARILY WITH TAPE UNTIL THE PLANNED SERVICE ACTION. IT WAS UNKNOWN WHICH COMPONENT WAS DAMAGED - THE SOCKET OR THE PLUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239605 ↗
• MalfunctionDec 15, 2023Application 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 PENDANT WAS D EFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335028 ↗
• MalfunctionOct 25, 2023Application 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 SYSTEM SWITCHED BETWEEN "READY" AND "STANDALONE MODE." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003801 ↗
• MalfunctionOct 16, 2023Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE X-RAY DETECTOR WAS SPORADICALLY OFF. 2D OR 3D SCANS WERE NOT POSSIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940847 ↗
• MalfunctionSep 27, 2023Radiation 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 3D SCAN WAS A NON-NAVIGATED SCAN. THE NAVIGATION AND IMAGING SYSTEM SETTINGS WERE PERFECT BUT THE 3D SCAN WAS A NON-NAVIGATED SCAN. BOTH NAVIGATION AND IMAGING WERE ABORTED CAUSING LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824245 ↗
• MalfunctionAug 22, 2023Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DOOR WAS NOT CLOSED. IT WAS NOT POSSIBLE TO CLOSE THE DOOR COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595908 ↗
• MalfunctionJul 12, 2023Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR WAS NOT CLOSED COMPLETELY. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306099 ↗
• MalfunctionJul 5, 2023Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCANS WERE INACCURATE. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DEFECTIVE COVERS. THE NEXT STEP WAS TO RECALIBRATE THE SYSTEM. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. WITH THE BLUE LUMBAR MODEL ON THE NAVIGATION IT WAS ABOUT 2 MILLIMETER INACCURATE. THE NAVIGATION WAS INACCURATE AND NOT THE SCANS. VERIFICATION WAS DONE WITH BOTH THE IMAGING SYSTEM AND THE NAVIGATION SYSTEM BY THE SYSTEM AND ALL WERE WITHIN TOLERANCE. NAVIGATION VERIFICATION WAS PERFORMED ON SITE. BOTH SIDES WITH THE FIELD OF VIEW (FOV) WERE 20 MM AND FOV 40 MM VERIFIED. NO INACCURACY WAS FOUND. SYSTEM WORKED AS INTENDED. SYSTEM CHECKOUT PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259960 ↗
• MalfunctionMay 12, 2023Application 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 WOULD NOT TAKE 2D IMAGES AFTER COMING FROM THE 3D SCAN MODE. THE SURGEON OPTED TO ABORT THE USE OF THE IMAGING SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THERE WERE SEVERAL CHECKS DONE WITH THE SYSTEM, AND THE MANUFACTURER REPRESENTATIVE (REP) IDENTIFIED THE COLLIMATOR AS THE BROKEN PART CAUSING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920421 ↗
• MalfunctionMar 31, 2023Imprecision; Material Deformation; Imprecision; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A NAVIGATION INACCURACY OF MORE THAN 2MM. THE INACCURACY ORIGINATED FROM THE IMAGING SYSTEM. THERE WAS A DEFECTIVE COVER DUE TO A CRASH. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658679 ↗
• MalfunctionFeb 6, 2023Application 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 PENDANT WOULD SOMETIMES NOT REACT WHILE PRESSING THE MOVEMENT SWITCHES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304547 ↗
• MalfunctionAug 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO TURN THE PENDANT TO THE LEFT OR RIGHT SIDE. THIS WAS FOUND DURING STORAGE OF THE SYSTEM. NO PATIENT WAS PRESENT. THE PROBABLE CAUSE WAS THAT THE PENDANT PLUNGER NEEDED TO BE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE PENDANT WAS STILL FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202106 ↗
• MalfunctionAug 1, 2022Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) AND MOBILE VIEW STATION (MVS) WOULD REBOOTS AND READY TO USE. AFTER SOME WHILE, THE SYSTEM WOULD  REBOOT/INITIATES AGAIN. THE PROBLEM WAS SOLVED BY SHUTTING DOWN AND REBOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138992 ↗
• MalfunctionJul 18, 2022Application 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 SYSTEM HAD A DEFECTIVE PENDANT. THE DISPLAY HAD NO FUNCTION. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047585 ↗
• MalfunctionApr 20, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED PRE-OPERATIVE TO A CERVICAL SPINAL FUSION. IT WAS REPORTED THAT THE IMAGING SYSTEM WAS UNABLE TO PERFORM X-RAY IMAGE ACQUISITIONS. IT WAS NOTED THAT EVERYTHING ON THE IMAGING SYSTEM APPEARED NORMAL DESPITE THE INABILITY TO PERFORM IMAGE ACQUISITIONS. THE SURGEON OPTED TO USE A C-ARM IN LIEU OF THE IMAGING SYSTEM FOR THE SUBSEQUENT PROCEDURE. ONCE THE IMAGING SYSTEM WAS PARKED OUTSIDE THE OPERATING ROOM (OR), IMAGING FUNCTIONALITY RETURNED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159583 ↗
• MalfunctionFeb 28, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE PENDANT WAS SPORADICALLY NOT WORKING. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624138 ↗
• MalfunctionJan 25, 2022Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM GOES DOWN. THE BATTERIES SHOWS CRITICAL STATE. THE NEXT STEP WAS FOR ALL THE BATTERY TRAYS TO BE REPLACED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS ISOLATED TO THE IMAGE ACQUISITION SYSTEM (IAS) AND THAT THE SYSTEM SHUT DOWN WITHOUT PROMPT FROM THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342996 ↗
• MalfunctionJan 7, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED  OUTSIDE OF A PROCEDURE THAT THE SECOND PENDANT WAS BROKEN, THE BUTTON DOES NOT WORK. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THAT IT BROKE DUE TO MISS-USE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191251 ↗
• MalfunctionOct 26, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED WHILE SETTING UP FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM WAS CLOSED BUT THE SYSTEM STATED THE GANTRY DOOR WAS OPEN. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698010 ↗
• MalfunctionOct 19, 2021Failure to Charge; Failure to Charge

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM BATTERIES WOULD NOT CHARGE. IT WAS NOTED THAT THE IMAGING SYSTEM BATTERIES HAD BEEN DISCHARGED PRIOR. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. THE FACILITY EXPRESSED CONCERNS THAT THE SYSTEM LACKED A DEEP DISCHARGE PROTECTION SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE IMAGE ACQUISITION SYSTEM (IAS) BATTERIES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656738 ↗