O-arm BI70002000 (UDI 00763000616564)Recalls & reported problems

Summary

The FDA's MAUDE database contains 466 adverse event reports that list this exact device (DI 00763000616564), received between Jul 22, 2022 and May 29, 2026 — classified as 7 injuries, 459 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (141 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. May 19, 2026Open, Classified

   Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

   Z-2451-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Jul 25, 2023Open, Classified

   Ground cable installed incorrectly.

   Z-2449-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 466 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE RAD TECHS HAD NOTICED A RING ARTIFACT ON PATIENT IMAGES DURING PHYSICS TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333108 ↗
• MalfunctionMay 21, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A PORTION OF THE DETECTOR BLOCK WAS INTERMITTENTLY DROPPING OUT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241072 ↗
• MalfunctionMar 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS >5MM INACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565846 ↗
• MalfunctionFeb 19, 2026Failure to Advance; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO OPEN WHILE AROUND THE PATIENT. ONCE SITE COMPLETED THE MANUAL OPEN-DOOR PROCEDURE THE PENDANT SAID OPEN DOOR MESSAGE. PATIENT WAS PRESENT BUT NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386413 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS UNABLE TO OPEN AROUND A PATIENT, AND THEY HAD TO PERFORM THE MANUAL DOOR OPEN PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332975 ↗
• MalfunctionFeb 4, 2026Incorrect, 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 THERE WAS A SECOND INSTANCE OF ALLEGED INACCURACY WITH THE SYSTEM. THE SITE BELIEVED A MISPLACED SCREW APPEARED LOW IN THE PEDICLE. THE SCREW WAS APPROXIMATELY 2¿3 MM OFF TARGET IN THE INFERIOR DIRECTION. THE SCREW WAS REMOVED AND REPOSITIONED USING A C-IMAGING SYSTEM. OF THE EIGHT SCREWS PLACED, SEVEN APPEARED TO BE CORRECTLY POSITIONED. MEDTRONIC NAVIGATION WAS ABORTED. IT OCCURRED INTRA OPERATIVELY AND THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. PATIENT PRESENT AT TIME OF EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT AN INCORRECT SERIAL NUMBER FOR THE IMAGING SYSTEM WAS ORIGINALLY PROVIDED. THE CORRECT SERIAL NUMBER FOR THIS CASE IS C3546.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256050 ↗
• MalfunctionJan 22, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SYSTEM WOULD NOT OPEN FULLY. THE UNIT WOULD BOOT UP TO 2D HOWEVER WHEN DEPRESSING THE OPEN BUTTON, THE DOORS PANELS WOULD NOT FULLY OPEN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142714 ↗
• MalfunctionJan 16, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT AFTER TAKING THE FIRST IMAGE, THE SITE ATTEMPTED TO TAKE ADJUSTMENTS FOR THE SECOND SPIN, BUT THE O2 WAS NO LONGER ABLE TO OPEN. NO FURTHER INFORMATION GIVEN AT THE TIME OF THE CALL. THIS ISSUE CAUSED UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092481 ↗
• MalfunctionDec 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED THAT AUGMEDICS SYSTEM BEING THE CAUSE RATHER THAN THE IMAGING SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922325 ↗
• MalfunctionDec 8, 2025Unintended System Motion; Unintended System Motion

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE SYSTEM WAS AROUND THE PATIENT DURING A CASE, WHEN ATTEMPTING TO DRIVE THE SYSTEM FORWARD AND CENTER IT, THE SYSTEM WAS ROLLING BACK. CLINICAL SERVICE REPORTED THE SYSTEM WAS UNABLE TO DRIVE FORWARD AND REQUIRED FORCE. THIS HAD OCCURRED INTRA OPERATIVELY. THERE WAS NO REPORTED DELAY AND NO PATIENT WAS PRESENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23738719 ↗
• MalfunctionNov 28, 2025Failure to Advance; Application Program Problem; Device Fell; Failure to Advance; Application Program Problem; Device Fell

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN OPENING THE GANTRY, A SCREW FELL OUT AND SITE CANNOT CLOSE IT. AFTER POWERING ON THE SYSTEM AN ERROR STATING "COMMAND SEQUENCE ABORTED, REQUESTING SEQUENCE" OCCURRED. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669331 ↗
• MalfunctionNov 25, 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 THERE WAS DIFFICULTY OPENING THE GANTRY. THE SITE STATED IT WAS TAKING AN EXTENDED AMOUNT OF TIME TO OPEN THE GANTRY, AND THEY HAD TO PUSH VERY HARD ON THE PENDANT FOR MOVEMENT TO OCCUR. THERE WAS NO REPORTED DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646045 ↗
• MalfunctionNov 18, 2025Failure to Advance; Material Deformation; Positioning Problem; Failure to Advance; Material Deformation; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT OPEN, CLOSE, OR DOCK. THE PENDANT INDICATED THAT THE GANTRY WAS OPEN DESPITE IT BEING CLOSED. REPRESENTATIVE ALSO MENTIONED THAT THE TOP PART OF THE DOOR WAS ASKEW FROM THE TOP PART OF THE GANTRY. TROUBLESHOOTING WAS PERFORMED AND TECHNICAL SERVICE ASKED THE SITE TO OPEN THE GANTRY ALL THE WAY, BUT THEY SAID THAT THE OPEN-GANTRY BUTTON DIDN'T DO ANYTHING. WHEN PRESSING THE DOCK BUTTON, THE GANTRY WOULD MOVE TOWARDS THE BASE, BUT JUST STOPS ABOUT WHERE IT'S SUPPOSED TO LOWER DOWN. WHEN PRESSING THE DOCK BUTTON AGAIN, IT WOULD NOT DO ANYTHING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581163 ↗
• MalfunctionNov 7, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR WOULDN'T OPEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494804 ↗
• MalfunctionNov 7, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ON BEHALF OF THE SITE THAT THE GANTRY WOULD NOT OPEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494614 ↗
• MalfunctionOct 30, 2025Display or Visual Feedback Problem; Radiation Output Problem; Display or Visual Feedback Problem; Radiation Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE IMAGES AND APPEARED THAT THE COLLIMATOR WAS NOT OPENING UP. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED AT THE CALL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422045 ↗
• MalfunctionOct 29, 2025Failure to Advance; Noise, Audible; Radiation Output Failure; Failure to Advance; Noise, Audible; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A UNKNOWN PROCEDURE. IT WAS REPORTED THAT AFTER A LONG SPIN, THE SYSTEM SAID 62 SECONDS. THE TIMER WAS STARTED TO COUNT DOWN, BUT NEVER SPUN. THE SITE WAS ABLE TO DO TWO SMALLER SPINS. AFTER SPINNING, THE SITE TRIED TO OPEN THE SYSTEM, AND IT WOULD NOT OPEN. THE SITE REBOOTED THE SYSTEM, AND THEY WERE ABLE TO OPEN BUT THEN IT MADE A LOUD NOISE WHILE DOCKING. THIS ISSUE OCCURRED INTRAOPERATIVELY, AND THERE WAS UNKNOWN DELAY TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412469 ↗
• InjuryOct 22, 2025Incorrect, 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 THERE WAS AN ALLEGED INACCURACY THAT HAD OCCURRED. AN ADVERSE PATIENT EVENT OCCURRED WHEN USING THIS SYSTEM. NO INFORMATION PERTAINING TO THE EVENT HAS BEEN PROVIDED AT THIS TIME. AN ADDITIONAL SURGERY WAS NEEDED SUE TO AN ADVERSE EVENT RELATED TO THE STUDY INDEX SURGERY. THERE WAS SEVERE STENOSIS. THERE WAS INTERVERTEBRAL THORACIC DISC DISORDER WITH MYELOPATHY, THORACIC REGION. THERE WAS FUSION EXTENSION THAT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356641 ↗
• MalfunctionOct 20, 2025Mechanical Problem; Failure to Advance; Noise, Audible; Mechanical Problem; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR WAS STUCK CLOSED AROUND A PATIENT. THE MANUFACTURER REPRESENTATIVE (REP) CALLED INTO THE OPERATING ROOM AFTER THE DOOR BECAME STUCK. THE REP REPORTED THAT THE DOOR WOULD MOVE AND RESPOND TO PENDANT COMMANDS EXCEPT FOR OPENING AND CLOSING THE DOOR. THE SITE HAD ATTEMPTED TO REBOOT THE SYSTEM SEVERAL TIMES PRIOR TO THE REP'S ARRIVAL. TROUBLESHOOTING WAS PERFORMED AND TECHNICAL SERVICES (TS) HAD THE REP ATTEMPT TO USE THE YELLOW OVERRIDE BUTTON TO OPEN THE DOOR, BUT IT WAS UNSUCCESSFUL. TS HAD THE REP ATTEMPT TO OPEN THE DOOR MANUALLY WITH THE RATCHET WRENCH AND T-PIN. THE REP REPORTED SEEING ORANGE SURFACE THROUGH THE T-PIN HOLE AND TURNING THE RATCHET COUNTER-CLOCKWISE BUT THE ORANGE SURFACE NEVER MOVED. THERE WAS A NOTABLE SCRATCH MARK ON THE ORANGE SURFACE THAT WAS USED TO CONFIRM LACK OF MOVEMENT. THE SITE CLAIMS TO HAVE HEARD A LOUD CLUNK WHILE THE DOOR WAS CLOSED. TS BELIEVES GANTRY CABLE MAY HAVE SNAPPED. THE SITE CONTINUED WITH THE PROCEDURE WITH THE PATIENT STILL IN THE SYSTEM AND TO REMOVE THE PATIENT AFTER THE PROCEDURE. BOTH NAV IGATION AND I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336787 ↗
• MalfunctionOct 17, 2025Incorrect, 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 THE FIRST THREE NAVIGATED SPINS, THE ACCURACY WAS OFF BY APPROXIMATELY 1 CM EACH TIME. JOHN THEN SWITCHED TO ANOTHER SPINE REFERENCE FRAME AND PERFORMED A FOURTH NAVIGATED SPIN, WHICH WAS ACCURATE. THE NDI CAMERA WAS POSITIONED FACING THE IMAGING SYSTEM¿S LEFT TRACKER EACH TIME. PATIENT WAS PRESENT. THERE WAS LESS THAN ONE HOUR OF SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323615 ↗
• MalfunctionOct 15, 2025Mechanical Problem; Failure to Advance; Mechanical Problem; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS STUCK IN A CLOSED POSITION. THERE WAS NO PATIENT PRESENT DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291164 ↗
• MalfunctionSep 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED "THE INACCURACY WAS APPROXIMATELY 2MM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071515 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Failure to Advance; Device Sensing Problem; Mechanical Problem; Failure to Advance; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM EXPERIENCED A SERIES OF ISSUES REGARDING THE GANTRY DOORS WHILE IN SURGERY AND UNABLE TO OPEN. THE PENDANT DISPLAYED A DOOR OPEN MESSAGE, DESPITE THE GANTRY BEING PHYSICALLY CLOSED. AS A RESULT, REPRESENTATIVE HAD THE SITE REBOOT THE SYSTEM, BUT THE MESSAGE PERSISTED UPON REBOOT. THE SITE ATTEMPTED TO OPEN THE SYSTEM GANTRY VIA THE PENDANT BUTTONS. HOWEVER, THE GANTRY WAS ONLY ABLE TO BE OPENED PARTIALLY. IT WAS NOT ENOUGH TO FULLY REMOVE THE PATIENT. REPRESENTATIVE WALKED THE SITE THROUGH LIFT AND SHIFTING THE IMAGE ACQUISITION SYSTEM (IAS) AROUND THE BED WITH THE PARTIALLY OPEN GANTRY. THE IAS SUCCESSFULLY CLEARED THE PATIENT/TABLE USING THIS METHOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935874 ↗
• MalfunctionAug 29, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WILL NOT OPEN. SITE REPORTED THAT THEY WERE ATTEMPTING TO GO OVER A PATIENT BUT THE SYSTEM WAS NOT PHYSICALLY OVER THE PATIENT YET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923035 ↗
• MalfunctionAug 28, 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. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916721 ↗