O-ARM® BI70002000 (UDI 00643169639683)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,667 adverse event reports that list this exact device (DI 00643169639683), received between Jan 9, 2017 and Sep 30, 2026 — classified as 1 death, 19 injuries, 3,647 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1,393 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

2. Apr 26, 2024Open, Classified

   Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

   Z-2026-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 3,667 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem; Unintended Electrical Shock

  Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that the door winch cable grade was a C or D and required replacement. (Door Winch Cable Grade C/D). Confirmed reported complaint, "Door Winch Cable Grade C/D." Cable failed visual inspection. Cable was showing signs of wear and fraying. Worn cable. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943457 ↗
• MalfunctionSep 29, 2026Mechanical Problem; Failure to Advance

  Medtronic received information regarding an imaging system being used during a unknown procedure. It was reported that the systems gantry was unable to close or open. Site reported that the sterile drape may be stuck. There was unknown delay. There was unknown impact on patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929359 ↗
• MalfunctionSep 3, 2026Failure to Advance; Device Sensing Problem; Positioning Problem; Radiation Output Failure; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50579841 ↗
• MalfunctionAug 12, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220459 ↗
• MalfunctionMay 13, 2026Adverse 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 TOGGLING BACK AND FORTH BETWEEN STANDALONE AND 2D MODE. NO FURTHER CASE DETAILS PROVIDED NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163999 ↗
• MalfunctionApr 29, 2026Failure to Advance

  MEDTRONIC RECEIVED THE INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO OPEN THE GANTRY BEFORE A CASE. GANTRY WAS CLOSED BUT PENDANT SAID THE DOOR WAS OPEN. NO OTHER INFORMATION AVAILABLE AT TIME OF CALL. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030464 ↗
• MalfunctionApr 24, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT WHEN TAKING A NON-NAVIGATED 3D SPIN, THE IMAGES WERE COMING UP STACKED ON TOP OF EACH OTHER. TROUBLESHOOTING, CALLER REPORTED UNABLE TO REBOOT SYSTEM, FOLLOWING THEIR TYPICAL PROTOCOL. NAVIGATION WAS ABORTED. IMAGING WAS ABORTED. NAVIGATION WAS ABORTED. THERE WAS SERIOUS INJURY TO THE PATIENT. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND UNKNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981112 ↗
• MalfunctionApr 14, 2026Unintended System Motion; Positioning Problem; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN CLOSING THE GANTRY DOOR AND GETS TO 1/4 OF THE WAY, IT APPEARED TO SLIDE FORWARD. THEY COULD STILL CLOSE THE SYSTEM AND EXPOSURE, BUT THE JARRING MOVEMENT FORWARD WAS CAUSING CONCERN WHEN CLOSING. THERE WAS ALSO AN "AIR FILLING NOISE" WHEN RAISING AND LOWERING (VERTICAL). NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876789 ↗
• MalfunctionApr 6, 2026Failure to Advance; Positioning Problem; 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 THEY COMPLETED A SPIN AND THE SYSTEM WAS UNABLE TO OPEN. THEY COULD NOT USE THE PENDANT BUTTONS TO OPEN AND NEEDED TO RESOLVE THE ISSUE BY USING THE YELLOW BUTTON AND THE PENDANT. THEY THEN COMPLETED A LIFT AND SHIFT WHEN THE TRANSPORT BRAKE BUTTON HAD ILLUMINATED BUT THE SYSTEM WOULD NOT DRIVE AFTER PRESSING. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED A LESS THAN ONE-HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791537 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT FAILED A WORK ORDER TO INDICATE THAT THE SYSTEM WAS RECALIBRATED DUE TO AN INACCURACY. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700239 ↗
• MalfunctionMar 25, 2026Noise, Audible

  IMAGING WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685635 ↗
• MalfunctionMar 24, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS UNABLE TO BE OPENED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675115 ↗
• MalfunctionMar 24, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED THE INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE IAS(IMAGING ACQUISITION SYSTEM) WAS STUCK IN INITIALIZATION. THIS WAS A SECOND OCCURRENCE OF THE SYSTEM EXPERIENCING SYSTEM BOOTING PLEASE WAIT ERROR ISSUE. TROUBLESHOOTING: MANUFACTURING REPRESENTATIVE PERFORMED THE FOLLOWING: TURNED IAS(IMAGING ACQUISITION SYSTEM) AND MVS(MOBILE VIEWING STATION) OFF. REBOOTED BOTH MVS(MOBILE VIEWING STATION) AND IAS(IMAGING ACQUISITION SYSTEM).TURNED OFF BOTH SYSTEMS AND UNPLUGGED UMBILICAL CORD. UNPLUGGED MVS(MOBILE VIEWING STATION) FROM WALL. TURNED IAS(IMAGING ACQUISITION SYSTEM) ON WITHOUT BEING CONNECT TO MVS(MOBILE VIEWING STATION).PLUGGED IAS(IMAGING ACQUISITION SYSTEM) INTO MVS(MOBILE VIEWING STATION) WHILE POWERED ON. ISSUE PERSISTED AFTER EACH STEP OF TROUBLESHOOTING. NO PATIENT PRESENT. ADDITIONAL INFORMATION STATING THAT ANOTHER CASE WAS SYSTEM BOOTING ERROR AND THIS WAS A STUCK IN INITIALIZATION ERROR AND THEY WERE NOT RELATED. THIS WAS NOT A SECOND OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673653 ↗
• MalfunctionMar 17, 2026Mechanical Problem; Unintended Electrical Shock

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE PROCEDURE. IT WAS REPORTED THAT THE HANDSWITCH CABLE HAS EXPOSED WIRING (DAMAGED HANDSWITCH CABLE / PM FINDING). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617612 ↗
• MalfunctionFeb 26, 2026Failure to Advance; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS FULLY CLOSED BUT SHOWED THAT THE DOOR WAS NOT CLOSED. THE GANTRY DID NOT OPEN AND WOULD NOT DOCK. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451936 ↗
• MalfunctionFeb 26, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT OPEN OR CLOSE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451357 ↗
• MalfunctionFeb 20, 2026Application 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 WORN AND ARE NOT RESPONSIVE TO OPEN AND CLOSE FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400232 ↗
• MalfunctionFeb 20, 2026Mechanical Problem; Component Missing; Failure to Advance; Device Sensing Problem

  ADDITIONAL INFORMATION STATING THAT VISUAL INSPECTION AND GENERAL CLEANING WERE PERFORMED. THE DOOR WINCH CABLE WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399478 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS HAVING DIFFICULTY OPENING AFTER A SPIN. SITE ATTEMPTED THE EMERGENCY OVERRIDE PROCEDURE BUT WERE UNABLE TO GET THE GANTRY TO OPEN. THEY ALSO REALIGNED THE COLLIMATOR. EVENTUALLY, AFTER SOME TIME, THE PENDANT RESPONDED AND THE GANTRY OPENED AS INTENDED. THIS RESULTED IN A TWO-MINUTE DELAY. THIS ISSUE OCCURRED INTRAOPERATIVELY, AND THERE WAS LESS THAN ONE HOUR DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331338 ↗
• MalfunctionFeb 12, 2026Noise, Audible; Device Fell

  ADDITIONAL INFORMATION RECEIVED. THERE WAS NO DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322586 ↗
• MalfunctionFeb 12, 2026Unintended Electrical Shock

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE POWER CABLE HAD AN EXPOSED WIRE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320421 ↗
• MalfunctionFeb 11, 2026Display or Visual Feedback Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS ISSUE WAS DETERMINED TO HAVE OCCURRED DUE TO PENDANT MALFUNCTION. THE PENDANT WAS REPLACED IN A RELATED CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311021 ↗
• MalfunctionFeb 5, 2026Mechanical Problem; Noise, Audible; Device Fell

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM WAS CAUGHT ON AN IV POLE AND THE SITE HEARD SOMETHING "SNAP INSIDE". SITE WENT TO DO A CALIBRATION AND HEARD ANOTHER SNAP BUT WAS ABLE TO FINISH. AFTERWARDS THEY OPENED THE GANTRY AND SAW A 1"X2" UNIDENTIFIED PIECE FALL OUT OF THE SYSTEM. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272092 ↗
• MalfunctionFeb 5, 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 DURING A SPINE CASE THE SITE DID A SPIN FOR AUTOMATIC REGURGITATION. THE SIGHT WAS VERIFYING ACCURACY AND FOUND THE ACCURACY WAS 4MM OFF. THE SIGHT ASSUMED THEY HAD BUMPED THE REFERENCE FRAME WHEN MOVING THE IMAGING SYSTEM SO THEY BROUGHT THE IMAGING SYSTEM BACK IN AND RAN ANOTHER SCAN. THEY WENT TO VERIFY ACCURACY AND FOUND THAT THE SCAN WAS OFF BY 4MM AGAIN. THE SIGHT ABORTED USE OF THE IMAGING SYSTEM AND OPTED TO USER A COMPETITOR'S IMAGING SYSTEM INSTEAD. THE REST OF THE PROCEDURE CONTINUED NORMALLY. THE CS NOTED THE NAVIGATION SYSTEM CAMERA WAS AT THE FOOT OF THE BED RATHER THAN THE HEAD WHICH WAS NOT TYPICAL FOR THE SITE AND MEANT THE CAMERA WAS POINTED AT THE OPPOSITE SIDE OF THE IMAGING SYSTEM THAN IT NORMALLY WAS. PATIENT WAS PRESENT. THERE WAS LESS THAN ONE HOUR OF SURGICAL DELAY AND UNKNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271780 ↗
• MalfunctionFeb 5, 2026Mechanical Problem; Failure to Advance; Device Sensing Problem; Radiation Output Failure

  MEDTRONIC RECEIVED THE INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE DOOR WAS NOT OPENING.NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265745 ↗