O-ARM® BI70002000 (UDI 00763000542849)Recalls & reported problems

Summary

The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 00763000542849), received between Dec 13, 2021 and Sep 23, 2026 — classified as 5 injuries, 254 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (96 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 259 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Advance; Noise, Audible

  Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that the gantry does not open when pressing the respective button on the pendant, and the gantry makes a loud sound when it does open. No patient was present at the time of event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865603 ↗
• MalfunctionJan 8, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DOOR WON'T OPEN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000424 ↗
• MalfunctionNov 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED REGARDING ALLEGED INACCURACY AND TO CHECK THE NAVIGATION ACCURACY. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602046 ↗
• MalfunctionOct 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 DURING A CASE, THE OPERATING ROOM STAFF HAD REPORTED ISSUES WITH OPENING THE IMAGING SYSTEM. THEY STATE THE SYSTEM OPENED, BUT THEY HAVE DIFFICULTY. SITE STATED HE CHECKED ON THE SYSTEM AND COULD NOT GET THE ISSUE TO BE REPLICATED, BUT OPERATING ROOM STAFF WAS ASKING FOR AN OFFICIAL SYSTEM CHECKOUT. THERE WAS UNKNOWN DELAY TO PROCEDURE AND UNKNOWN IMPACT ON PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391283 ↗
• MalfunctionOct 27, 2025Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback 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 USERS ARE HAVING ISSUES WITH THE STITCHING FEATURE OF THE SYSTEM AS UNABLE TO STITCH IMAGES. ALSO REPORTED POSSIBLY USER ERROR, BUT SITE REQUESTED TO LOOK AT THE SYSTEM AND ASSIST THEM WITH THIS ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388429 ↗
• MalfunctionSep 2, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE X-STAGE COVER WAS DAMAGED DURING TRANSPORT FROM SITE. REPAIR WOULD BE COVERED BY MEDTRONIC COST CENTER. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932500 ↗
• MalfunctionAug 25, 2025Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback 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 BUTTONS ON THE SYSTEM WERE INTERMITTENT AND THE SOFTWARE WAS FLIPPING THE IMAGES, CAUSING FRUSTRATION. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881886 ↗
• MalfunctionAug 19, 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 IMAGING SYSTEM FAILED TO OPEN WHILE THE PATIENT WAS PRESENT. THE DOOR ATTEMPTED TO OPEN BUT DID NOT FULLY DISENGAGE. AS A RESULT, THE MANUAL DOOR RELEASE PROCEDURE HAD TO BE PERFORMED, CAUSING A 10-MINUTE DELAY. THERE NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842711 ↗
• MalfunctionJul 23, 2025Adverse Event Without Identified Device or Use Problem; Radiation Output Failure; Adverse Event Without Identified Device or Use Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SYSTEM WOULD NOT STAY IN X-RAY MODE AND KEEPS ON RESTARTING. ENTIRE SYSTEM REBOOTING. SYSTEM WAS DOWN. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576623 ↗
• MalfunctionJul 17, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DOORS WOULD NOT FULLY OPEN OR CLOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528913 ↗
• MalfunctionJul 8, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS SIGNIFICANTLY DELAYED WHEN OPENING BACK UP. IT TAKES A LONG TIME, AND VERY FIRM PRESSES FOR GANTRY TO FULLY OPEN. THERE WAS NO PATIENT INVOLVED. PROBABLE CAUSE SEEMED TO BE POTENTIAL PENDANT. ADDITIONAL INFORMATION STATING THAT FROM FILED SERVICE ENGINEER (FSE), "THIS HAS BEEN REPORTED ABOUT 10 TIMES. MOST SYSTEMS HAVE THIS ISSUE. WHEN THE DOOR IS OPENING SLOWLY, YOU HAVE TO LIFT OFF THE BUTTON AND REPRESS IT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435053 ↗
• MalfunctionJul 7, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM GANTRY WOULD NOT FULLY OPEN AND THAT SITE HAD TO USE THE EMERGENCY WRENCH TO GET IT FULLY OPEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414015 ↗
• MalfunctionJul 7, 2025Failure to Advance; Noise, Audible; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR OF THE IMAGING SYSTEM WAS NOT FULLY CLOSING AND WAS MAKING CLICKING SOUNDS, AND SUBSEQUENTLY, THE DOOR WOULD NOT OPEN. THIS ISSUE OCCURRED INTRAOPERATIVELY, AND AS A RESULT, MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED. THE PATIENT WAS PRESENT DURING THE EVENT. TROUBLESHOOTING INVOLVED USING AN ALTERNATE OPEN BUTTON TO EXTRACT THE GANTRY FROM THE PATIENT AND TABLE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412857 ↗
• MalfunctionJul 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 PENDANT OPEN BUTTON WAS NOT WORKING PROPERLY. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412517 ↗
• 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 THE GANTRY WOULD NOT OPEN DURING A CASE. AS A TROUBLESHOOTING STEP MANUAL DOOR OPEN PROCEDURE RESOLVED THE ISSUE. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383335 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM DOOR DOES NOT CLOSE. IT WAS TRIED SEVERAL TIMES, BUT THE PROBLEM COULD NOT BE RESOLVED, THIS TIME, THE DOOR COULD NOT BE OPENED. IMAGING SYSTEM USAGE WAS DISCONTINUED. IT OCCURRED INTRA OPERATIVELY AND PATIENT PRESENT AT TIME OF EVENT. ADDITIONAL INFORMATION RECEIVED "THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON THE PATIENT OUTCOME".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381531 ↗
• MalfunctionJul 1, 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 SYSTEM WAS UNABLE TO OPEN WHILE AROUND A PATIENT. REPRESENTATIVE REBOOTED THE SYSTEM THREE TIMES - ISSUE UNRESOLVED AND PERFORMED MANUAL OPENING PROCESS - ISSUE UNRESOLVED. ALSO REPORTED THAT ANOTHER IMAGING SYSTEM WAS USED WHILE THE INITIAL IMAGING SYSTEM WAS STILL AROUND THE PATIENT. REPRESENTATIVE REPORTS THAT THE GANTRY WOULD GO UP AND DOWN BUT WHEN PERFORMING MANUAL OPEN PROCESS, GEARS LOOKED MISALIGNED AND THERE WAS RESISTANCE. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY AND NAVIGATION AND IMAGING WERE ABORTED. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374755 ↗
• MalfunctionJul 1, 2025Radiation Output Failure; Radiation Output Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED INTRAOPERATIVELY DURING AN OPEN SPINAL FUSION. 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 22368722 ↗
• MalfunctionJun 30, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PENDANT SAID RADIATION DISABLED. TECHNICAL SERVICE CONFIRMED THAT THE IMAGING ACQUISITION SYSTEM (IAS) KEY WAS HORIZONTAL AND NOT DAMAGED, BUT THE IAS DONGLE WAS MISSING FROM THE SYSTEM AND HAD TAPE OVER THE PORT. THERE WAS A PATIENT PRESENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED. THERE WAS NO ISSUE WITH THE SYSTEM. IT WAS OPERATING AS EXPECTED AND THEY WERE CURRENTLY USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355455 ↗
• MalfunctionJun 26, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE LOCAL RE PRESENTATIVE (CC) OPENED THE GANTRY, IT WOULD ONLY OPEN HALFWAY AND THEN IT WOULD STOP. THE GANTRY WOULD STILL MOVE IN THE FORWARD/BACKWARD AND SIDE TO SIDE MOTION. THEY WERE UNABLE TO CLOSE THE GANTRY AND MANUALLY OPENED ALL THE WAY AND IT WOULD STILL NOT CLOSE, SO THEY MANUALLY CLOSED IT AND REBOOTED AND ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334399 ↗
• MalfunctionJun 25, 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 DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE "PUSH BUTTON DIDN'T WORK." IT WAS NOT KNOWN IF THE SITE MEANT THE OPEN GANTRY BUTTON ON THE PENDANT OR THE EMERGENCY GANTRY OPEN BUTTON. THE SITE HAD TO MANUALLY CRANK THE GANTRY OPEN. NO FURTHER INFORMATION PROVIDED. IT WAS REPORTED THAT THE BUTTONS WERE HARD TO PRESS, BUT THE SYSTEM WAS PERFORMING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325744 ↗
• MalfunctionJun 24, 2025Mechanical Problem; Unintended System Motion; Mechanical Problem; Unintended System Motion

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN DRIVING THE SYSTEM, IT WAS NOT FUNCTIONING AS DESIGNED. CALLER REPORTED SYSTEM "GOING FAST, THEN SLOW AND JOLTING". NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313537 ↗
• MalfunctionJun 21, 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 THE PROCEDURE. IT WAS REPORTED THAT THE PENDANT BECAME UNRESPONSIVE WHILE SETTING A MEMORY PRESET FOR 3DLS. REBOOTING RESOLVED THE ISSUE. THIS OCCURRED DURING TRAINING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303721 ↗
• MalfunctionJun 18, 2025Application Program Problem; Radiation Output Failure; Application Program Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THEY RECEIVED A LIGHTING BOLT ICON FOR UNABLE TO TAKE 2D X-RAY WAS DISABLED. REBOOTED SYSTEM AND CHECKED UMBILICAL CABLE AND STILL UNRESOLVED. IMAGING WAS ABORTED. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND UNKNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285746 ↗
• MalfunctionJun 16, 2025Application 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 A IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS STUCK IN INITIALIZING SYSTEM PLEASE WAIT AND X-RAY WAS DISABLED ON THE PENDANT. CLINICAL SPECIALIST PERFORMED A MOTION CALIBRATION, WHICH CLEARED, BUT THE SYSTEM WAS UNABLE TO MOVE PASS THE INITIALIZING SCREEN. IN TROUBLESHOOTING, CONFIRMED NO DAMAGE TO THE IAS (IMAGE ACQUISITION SYSTEM) KEY, IAS DONGLE, AND UMBILICAL. PERFORMED A REBOOT WITH THE UMBILICAL DISCONNECTED. THERE WAS NO EFFECT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213671 ↗