O-ARM® BI70002000 (UDI 00763000134518)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000134518), received between Jun 26, 2020 and Nov 4, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (11 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. 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 ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Mechanical Problem; Failure to Advance; Mechanical Problem; Failure to Advance

  MEDTRONIC RECEIVED THE INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THERE WAS PROBLEM CLOSING DOOR OF IMAGING SYSTEM, ITS NOT CLOSING AND PENDANT NOT SHOWING DOOR WAS OPEN. ROTOR WAS MIS ALIGNED. NO PATIENT INVOLVED. EVENT NOT QUALIFIES FOR REPORTING, REPORTED IN ERROR. THIS IS BEING UPDATED TO NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463213 ↗
• MalfunctionDec 6, 2024Positioning Problem; Application Program Freezes or Fails to Launch; Positioning Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT THE SITE TRYING TO COMPLETE THE HOMING PROCEDURE WAS DIFFICULT. PENDANT M BUTTON CONTACT WAS INCONSISTENT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865328 ↗
• MalfunctionAug 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE AXIAL AND CORONAL IMAGES SHOWED ANTERIOR AND POSTERIOR BOTH LABELLED CORRECTLY. HOWEVER, SAGITTAL IMAGES HAVE THE BACK OF THE SPINE LABELLED AS ANTERIOR AND THE FRONT OF THE PATIENT AS POSTERIOR. THERE WAS NO PATIENT IMPACT, THE IMAGES WHERE USED FOR NAVIGATION. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007573 ↗
• MalfunctionApr 2, 2024Unintended System Motion; Unintended System Motion

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM THAT THE SYSTEM SURGED FORWARD DUE TO A FAULTY DRIVE. THE SITE HAD NOT REPORTED ANY DRIVE ERRORS, BUT THIS WAS A SERIOUS ERROR IN THE DRIVING. SURGING FORWARD AND TO THE RIGHT, MEANING THE LEFT-HAND STRAIN GAUGE AND MOTOR WHERE ACTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019568 ↗
• MalfunctionFeb 6, 2024Unintended System Motion; Unintended System Motion

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) SOMETIMES JUMPED IN REVERSE WHEN THE DRIVE HANDLE WAS ACTIVATED. IT WAS NOTED THAT THIS COULD HAPPEN WHEN THE SYSTEM WAS LEFT IDLE FOR A PERIOD OF TIME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649592 ↗
• MalfunctionMay 1, 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 CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ERROR INITIALIZING COLLIMATOR MESSAGE. THE SYSTEM ALSO FAILED TO BOOT FULLY INTO 2D MODE. THERE WAS A DELAY OF LESS THAN ONE HOUR BEFORE THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843374 ↗
• MalfunctionApr 3, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE OCCURRED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663483 ↗
• MalfunctionApr 3, 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 WAS NOT EXPOSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662630 ↗
• MalfunctionJul 4, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE RIGHT SIDE TRACKER WAS FLICKERING IN STEALTH CAMERA VIEW. GPIO REPLACED BUT FLICKERING REMAINS. CABLE AND/OR TRACKER MAY BE FAULTY. REPLACEMENT REQUIRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911830 ↗
• MalfunctionJun 3, 2022Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGING ACQUISITION SYSTEM (IAS) SPED UP BACKWARDS UNCONTROLLABLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593827 ↗
• MalfunctionNov 30, 2021Physical Resistance/Sticking; Application Program Freezes or Fails to Launch; Physical Resistance/Sticking; Application Program Freezes or Fails to Launch

  (B)(6) 2021, (B)(4), (REP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE DURING AN INSTALLATION. IT WAS REPORTED THAT THE IMAGING SYSTEM WOULD NOT BOOT INTO 2D IMAGE ACQUISITION FUNCTIONALITY AND THE MOTION BAR SCROLLED CONTINUOUSLY. ADDITIONALLY IT WAS REPORTED THAT A MOVEMENT ERROR OCCURRED AND THERE WAS NO 2D/3D IMAGING. ERROR LOGS FOUND AN ERROR WITH THE POSITIONER, ADDITIONALLY, WIRING WAS FOUND TO BE TIGHT TO THE POSITIONER'S AND INTERFACE BOARDS. A RJ45 SOCKET ON THE UNIT APPEARED TO BE CRACKED AND THE CONNECTION WAS INTERMITTENT FROM THE POSITIONER BOARD, RESULTING IN A BOOT FAILURE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893929 ↗
• MalfunctionSep 28, 2021Positioning Problem; Application Program Freezes or Fails to Launch; 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 SYSTEM HAD A PROBLEM WITH STARTING UP WITH THE PROGRESS BAR FOR MOTION ON PENDANT STUCK ON GREEN ALL THE WAY TO THE RIGHT AND NEVER GETTING TO 2D. THE SYSTEM WAS INTERMITTENTLY REVERSING ABRUPTLY WHEN DEADMAN SWITCH ON DRIVE HANDLE ENABLED. A MANUFACTURER REPRESENTATIVE TRIED TO REMOTELY TROUBLESHOOT THE FAULT BUT COULD NOT RESOLVE THE ISSUE BY HAVING THE CLINICAL REPRESENTATIVE TRYING A NUMBER OF SHUTDOWN AND RESTARTS. THE LOGS SHOWED FOR ERROR "DMCEXCEPTION CAUGHT ON POSITIONER CONTROLLER" INITIALLY FOLLOWED IMMEDIATELY AFTERWARDS WITH GANTRY AND ROTOR ERRORS. ADDITIONAL TROUBLESHOOTING WAS PERFORMED THROUGH REMOTE SUPPORT. THE REPRESENTATIVE ASKED THE SITE TO INITIALLY TRY TO PING ALL THREE CONTROLLERS FROM REMOTE DESKTOP. THE POSITIONER CONTROLLER WAS NOT RESPONDING TO PING COMMAND. THE REPRESENTATIVE ADVISE THE SITE TO REMOVE THE BOTTOM POSITIONER COLUMN COVERS TO CHECK STATUS OF THE POSITIONER CONTROLLER. ONLY ONE GREEN LED WAS LIT ON CONTROLLER. THE SITE TRIED TO RESEAT THE NETWORK CABLE BUT THE PROBLEM WAS STILL PRESENT. WITH REMOTE GUIDANCE, T HE POSITIONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539559 ↗
• MalfunctionSep 22, 2021Positioning Problem; Application Program Freezes or Fails to Launch; Positioning Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED DURING PRE-OP. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WOULD ONLY DRIVE IN THE REVERSE DIRECTION. AFTER POWERING DOWN, THE IAS WOULD NOT FULLY BOOT UP- X RAY AND THE MOBILE VIEWING STATION (MVS) WAS READY, BUT INITIALIZING SYSTEM WAS NOT COMPLETING. THE MVS WAS FULLY BOOTING WITH NO ERRORS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED, AS WELL AS THAT THERE WAS NO PATIENT IMPACT AND NO DELAY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE MOVING THE SYSTEM DURING PER-OP, BEFORE THE SYSTEM ENTERED THE THEATRE SPACE. SURGERY CONTINUED WITH A NON-MEDTRONIC SYSTEM. THE SYSTEM WAS POWERED OFF AND MANUAL CLUTCH ENGAGED SO IT COULD BE MOVED BACK TO ITS LIVING LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514308 ↗
• MalfunctionJun 21, 2021Noise, Audible; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Noise, Audible; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE SYSTEM WAS REPAIRED AND IT WAS DETERMINED THERE WAS A FAILURE IN THE CABLE CHAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031914 ↗
• MalfunctionMay 26, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WILL NOT TAKE 3D IMAGES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886349 ↗
• MalfunctionMay 13, 2021Failure to Power Up; Failure to Power Up

  ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM WAS PLUGGED IN WHILE IT WAS IN STORAGE. IT WAS FOUND THE INCOMING 230V FUSES HAD BLOWN. ONCE THE FUSES WERE REPLACED, AND THE LOWER CIRCUIT BREAKER TURNED ON, THE SYSTEM POWERED UP FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816837 ↗
• MalfunctionMar 19, 2021Failure to Charge; Application Program Freezes or Fails to Launch; Failure to Charge; 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 VIEWING STATION (MVS) WAS NOT TURNING ON AND IMAGE ACQUISITION STATION (IAS) WAS NOT CHARGING. THE CUSTOMER REQUESTED A REPRESENTATIVE COME TO THE SITE. NO PATIENT WAS PRESENT. THE CUSTOMER REPORTED THAT THE IAS WAS ON AND MOVED WHILE THE MVS WAS OFF AND THE SYSTEM WAS PLUGGED INTO A POWER POINT. IT WAS BELIEVED THAT EXCESS ARCING WHEN PLUGGED IN AND UNDER LOAD CAUSED THE FUSES TO TRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526895 ↗
• InjuryJan 19, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD BEEN GIVEN A GA, POSITIONED AND INCISIONS MADE FOR PLACEMENT AND SET UP OF NAVIGATED INSTRUMENTATION. THE PATIENT WAS SELF-FUNDED AND HAD TAKEN TIME OFF WORK FOR THE SURGERY. ANESTHESIA HAD BEEN GIVE PRIOR TO THE PROCEDURE BEING ABORTED. AN INCISION HAD BEEN MADE PRIOR TO THE PROCEDURE BEING ABORTED. A SPINE FUSION WAS BEING PERFORMED WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194950 ↗
• InjuryJul 9, 2020Imprecision; Imprecision

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS NOTED THAT ALL FOUR SCREWS WERE NOT ACCURATELY PLACED. ADDITIONALLY, TWO AUTOMATIC RE GISTRATIONS WERE PERFORMED ON THE PRIMARY NAVIGATION IMAGE ACQUISITION AND IMPLANT VERIFICATION ACQUISITION. IT WAS NOTED THAT THE REFERENCE FRAME WAS PLACED ON THE T9 VERTEBRAE"

  Patient problems: Tissue Damage

  MAUDE report 10251865 ↗
• MalfunctionJun 26, 2020Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT DURING TROUBLESHOOTING, THE X AXIS DRIVE WAS TESTED WITH THE Z AXIS DRIVE AND IT WAS CONFIRMED THAT THE PROBLEMS WITH THE X DRIVE WERE LOCALIZED TO THE POSITIONER CONTROLLER.

  Patient problems: No Patient Involvement

  MAUDE report 10200597 ↗