O-ARM® BI70002000 (UDI 00763000068066)Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00763000068066), received between Mar 11, 2019 and Sep 25, 2026 — classified as 2 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (58 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Smoking; Arcing; Application Program Freezes or Fails to Launch

  Medtronic received information regarding an imaging system being used for a procedure. It was reported that the site had sparks and smoke emanating from the interconnect cable. patient was present but unknown procedure details. Additional information stating that "generator not booting correctly."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900404 ↗
• MalfunctionJul 3, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD EXPERIENCED INTERMITTENT ISSUES OPENING THE GANTRY. AND SITE SAID THEY HAD TO USE THE YELLOW BUTTON OPEN PROCEDURE TO OPEN THE GANTRY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396573 ↗
• MalfunctionJun 27, 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 DOOR GOT STUCK ABOUT A QUARTER OF THE WAY WHEN ATTEMPTING TO OPEN THE GANTRY FROM AROUND A PATIENT. IT WOULD NOT CLOSE OR OPEN AFTER IT GOT STUCK. THE SITE REBOOTED THE SYSTEM, BUT THAT DIDN'T RESOLVE THE ISSUE. THE SITE RESORTED TO OPENING THE GANTRY MANUALLY TO REMOVE IT FROM AROUND THE PATIENT. THEY HAD ANOTHER IMAGING SYSTEM THAT THEY USED TO CONTINUE THE CASE. THERE WAS A DELAY OF ABOUT 10 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343952 ↗
• MalfunctionJun 26, 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 SITE WAS UNABLE TO CLOSE THE GANTRY AROUND THE PATIENT. THEY REBOOTED THREE TIMES BEFORE IT WOULD CLOSE. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS NOT THAT THE GANTRY WOULD NOT CLOSE, BUT THAT IT WOULD NOT OPEN. THE SITE WENT TO PERFORM A POST OPERATIVE SPIN ON THE PATIENT, AND THEY WERE NOT ABLE TO OPEN THE GANTRY TO GET THE PATIENT OUT. A MANUAL DOOR OPEN WAS DONE TO OPEN THE GANTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337534 ↗
• MalfunctionMay 12, 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 PENDANT BUTTONS WERE FAULTY ON THE SYSTEM. RADIOLOGY REPORTED WHEN ONE BUTTON WAS PUSHED, IT WOULD ACTIVATE ANOTHER. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003446 ↗
• MalfunctionApr 29, 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 THE 3D BUTTON ON THE HAND SWITCH WAS UNRESPONSIVE. UPON TROUBLESHOOTING, THE FOOTSWITCH WAS FUNCTIONING AS INTENDED. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923992 ↗
• MalfunctionJan 31, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. DURING A PROCEDURE, THE IMAGING SYSTEM WAS UNABLE TO TAKE 2D IMAGE ACQUISITIONS. THE SYSTEM HAD TO BE REBOOTED TO RESTORE FUNCTIONALITY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORT. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THIS HAPPENED DURING A SPINAL FUSION PROCEDURE. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282842 ↗
• 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE HAND SWITCH WAS NOT ALLOWING THE SITE TO TAKE SHOTS. THE FOOTSWITCH WAS STILL WORKING AND ALLOWING THEM TO TAKE SHOTS. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233473 ↗
• MalfunctionJan 3, 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT OPEN OR CLOSE WHEN PENDANT BUTTON WAS PRESSED. NEITHER THE OPEN OR CLOSE BUTTON WERE WORKING. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064350 ↗
• MalfunctionDec 11, 2024Failure to Advance; Radiation Output Failure; Failure to Advance; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT RIGHT BEFORE TAKING 3D SPIN, THEY CLOSED THE GANTRY AROUND THE PATIENT BUT IT WOULD NOT GET A GREEN LIGHT READY TO SHOOT ON THE MVS STACK LIGHT. REOPENED AND CLOSED AND ISSUE PERSIST. PULLED DOWN ON THE COVER AND THEN THE GANTRY CLOSED ALL THE WAY AND THEY GOT A GREEN LIGHT ON THE STACK. THERE WAS NO PATIENT IMPACT AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904041 ↗
• MalfunctionNov 15, 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 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO ACQUIRE 2D IMAGES. AFTER REBOOTING, THE SYSTEM BOOTED TO A BLUE SCREEN. THE ISSUE WAS RESOLVED AFTER BOOTING THE SYSTEM THREE TIMES. THIS RESULTED IN A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696001 ↗
• MalfunctionNov 14, 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 DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE SYSTEM WAS HAVING ISSUES TAKING IMAGES AND RESPONDING. WHEN THEY WENT TO TAKE 2D IMAGE, IT WOULD NOT PERFORM THE X-RAY SO THE MANUFACTURER REPRESENTATIVE (REP) REBOOTED SYSTEM. THEY WERE THEN ABLE TO TAKE THE 2D SHOT. THEY FLIPPED TO DO 3D, AND AGAIN WAS UNABLE TO SPIN. THE REP REBOOTED AND WAS ABLE TO TAKE BOTH SHOTS. WHEN THE CASE WAS OVER, THE OPEN GANTRY BUTTON WAS NOT RESPONDING AND SO REP HAD TO REBOOT ONCE MORE TO BE ABLE TO OPEN GANTRY. IT WAS NOTED THAT THE SUSPECTED CAUSE WAS THAT THE SITE DID NOT WAIT FOR THE SYSTEM TO FULLY BOOT BEFORE TRYING TO SCAN. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688597 ↗
• MalfunctionNov 5, 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 WAS ABLE TO TAKE 2D IMAGES, BUT UNABLE TO TAKE A 3D SPIN. REBOOTING TWICE HAD NO EFFECT. SITE WOULD USE ANOTHER IMAGING SYSTEM TO COMPLETE THIS CASE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. PATIENT IMPACT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608431 ↗
• MalfunctionOct 24, 2024Application Program Problem; Noise, Audible; Radiation Output Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Noise, Audible; Radiation Output Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT HALFWAY THROUGH A SPIN, THE SYSTEM MADE A NOISE AND ENTERED STANDALONE MODE. ALSO PENDANT REPORTED RADIATION DISABLED. THE ISSUE OCCURRED INTRA OPERATIVELY CAUSING LESS THAN 1HR SURGICAL DELAY. IMAGING WAS ABORTED AND NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520591 ↗
• MalfunctionOct 23, 2024Positioning Problem; Radiation Output Failure; Positioning Problem; 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 EXPOSE. THE SYSTEM INITIALLY WORKED DURING THE CASE BUT LATER AFTER TAKING FOUR SPINS, IT STOPPED WORKING. THE USER TRIED TO DOCK THE SYSTEM BUT IT WOULD NOT RESPOND. THE USER SAID THAT THE SYSTEM NEEDED TO BE DOCKED TO LEAVE THE OPERATING ROOM. THE SYSTEM WAS THEN STUCK IN THE OPERATING ROOM. MEDTRONIC IMAGING WAS ABORTED. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514253 ↗
• MalfunctionOct 14, 2024Mechanical 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 DURING A PROCEDURE (UNKNOWN). IT WAS REPORTED THAT THE SITE SAW SOME UNEXPECTED PENDANT RESPONSES WHILE IN SURGERY. SITE REPORTS TRIED TO CHANGE THE KILO VOLT VALUES USING THE APPROPRIATE BUTTONS BUT SEEING OTHER IMAGING/MOVEMENT OPTIONS CHANGE INSTEAD. THERE WAS NO PATIENT PRESENT DURING THE EVENT. THE SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436935 ↗
• MalfunctionSep 30, 2024Application Program Problem; Radiation Output Failure; Application Program Freezes or Fails to Launch; Application Program Problem; 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 THE SYSTEM WAS STUCK IN INITIALIZING WITH THE RADIATION SYMBOL DISABLED. THEY TRIED CLEARING THE E-STOP, REBOOTING, AND RESEATING THE UMBILICAL WITH LITTLE SUCCESS. IT OCCURRED INTRA OPERATIVELY AND REPORTED NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATING THAT AT THE REPORTABLE EVENT DELAYED HAPPENED APPROXIMATELY 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331387 ↗
• MalfunctionAug 26, 2024Noise, Audible; Radiation Output Problem; Noise, Audible; Radiation Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS USED FOR 5 DIFFERENT SPINS, BUT ON THE 6TH TIME, THE UNIT STARTED BEEPING. IT WAS NOTED THE BATTERY STATUS WAS FULL. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS FOUND THAT THE SYSTEM WOULD DISPLAY EARLY TERMINATION DURING A 3D SPIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070141 ↗
• MalfunctionAug 13, 2024Failure 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 PENDANT WOULD NOT ALLOW THEM TO CLOSE AND WILL SOMETIMES NOT ALLOW THEM TO OPEN. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS LESS THAN ONE HOUR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973707 ↗
• MalfunctionJul 12, 2024Application Program Problem; Device Sensing Problem; Radiation Output Failure; Application Program Problem; Device Sensing Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE CLOSED THE GANTRY, THE PENDANT STILL SAID THE GANTRY WAS OPEN SO THEY WERE UNABLE TO TAKE A SPIN. THERE WAS A DOOR OPEN WARNING.  THE SITE OPENED AND CLOSED THE DOOR, AND GENTLY PULLED DOWN ON THE COVER, WHICH RESOLVED THE ISSUE. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730678 ↗
• MalfunctionJun 27, 2024Malposition of Device; Malposition of Device

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE REGION OF INTEREST CHANGING WITHOUT BEING PROMPTED. THIS WAS NOTICED DURING A 3D SPIN, AND AFTER ADJUSTING THE KV AND MAS. THE REGION OF INTEREST WAS RESET AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624917 ↗
• MalfunctionJun 21, 2024Device Damaged Prior to Use; Application Program Problem; Device Damaged Prior to Use; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE PERFORMING A 2D LONG FILM UPGRADE ON THE SYSTEM, THE COLLIMATOR THAT CAME WITH THE UPGRADE KIT WAS FOUND TO BE BAD AT INSTALL. NO PATIENT PRESENT. THE PROBABLE CAUSE WAS SUSPECTED TO BE AN OUT OF BOX FAILURE (OOBF) COLLIMATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588228 ↗
• InjuryJun 19, 2024Premature Discharge of Battery; Failure to Advance; Noise, Audible; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Premature Discharge of Battery; Failure to Advance; Noise, Audible; Unexpected Shutdown; 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 WHILE THE SITE WAS TAKING THE ANTERIOR POSTERIOR (AP) AND LATERAL SCOUT IMAGES, THE PENDANT SCREEN WENT BLACK AND THE SYSTEM LOST POWER. THE SITE TRIED TO OPEN THE GANTRY BUT THERE WAS NO POWER. THE IMAGE ACQUISITION SYSTEM (IAS) WOULD NOT REBOOT AND THE PENDANT SCREEN WOULD NEVER LIGHT BACK UP. THE SITE MANUALLY OPENED THE GANTRY DOOR OPEN AND HEARD A LOUD POP, AND WAS UNABLE TO OPEN GANTRY. THE SITE PUSHED TO EDGE OF BED. THEY HAD TO CANCEL TWO CASES AS WELL AS THE CASES TOMORROW. THERE WAS AN HOUR OR LONGER DELAY IN SURGERY. THE USE OF NAVIGATION AND IMAGING WERE ABORTED. THE SURGERY WAS ABORTED AND RESCHEDULED FOR A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568689 ↗
• MalfunctionJun 18, 2024Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT WHILE IN PROCEDURE, THE SYSTEM WOULD BEGIN TO PERFORM A 3D SPIN, BUT WILL ABORT THE SCAN. THE SITE ATTEMPTED TO SWITCH FROM THE HANDSWITCH TO THE FOOT PEDAL AS WELL AS RESTARTING THE SOFTWARE. THERE WAS NO ERROR MESSAGE PRESENT. THEY POWERED OFF THE SYSTEM AND REMOVED FROM WALL POWER FOR 3 MINUTES. AFTER POWER THE SYSTEM ON THE ISSUE REOCCURRED. MEDTRONIC IMAGING WAS ABORTED. THERE WAS A DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559147 ↗
• MalfunctionMay 22, 2024Radiation Output Failure; Radiation Output Failure

  2024-MAY-15 00800245 (REP): MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO TAKE 2D SHOTS WHILE IN SURGERY. THE SITE SWITCHED TO ANOTHER SYSTEM TO CONTINUE SURGERY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THE REPRESENTATIVE WAS UNABLE TO REPLICATE ISSUE. THE LOGS INDICATE EMERGENCY RESET BUTTON WAS NOT PRESSED FOR A LONG TIME, THEREFORE THE SYSTEM WAS NOT FULLY BOOTED.  THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373190 ↗