O-ARM® BI70002000 (UDI 00763000132378)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,132 adverse event reports that list this exact device (DI 00763000132378), received between Oct 8, 2018 and Sep 29, 2026 — classified as 14 injuries, 2,118 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (882 reports).

2 FDA recall records name this device's identifier, 1 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. 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 25 most recent of 2,132 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Unintended Electrical Shock

  Medtronic received information regarding an imaging system being used outside of the procedure. It was reported that the ethernet cable had exposed wiring. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928484 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Medtronic received information regarding an imaging system being used during a cervical spine procedure. It was reported that during a cervical spine case they felt they were 5mm off (inferior) after the spin. They swapped the frame clamp and they were still off by 5mm (inferior) even after re-spinning with a new clamp (Alleged Inaccuracy). As they worked towards the frame they found that accuracy improved, but was never perfect. Additional information received "Resolution confirmed on call". This system had since been used with an AXiS and was seemed to be accurate".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916958 ↗
• MalfunctionMay 21, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD ARTIFACTS SHOWING UP IN BOTH THE 2D AND 3D IMAGES FOR SCANS. THE IMAGE LOOKS LIKE A BLACK VERTICAL STRIPE ACROSS THE LEFT SIDE OF THE IMAGE. THERE WAS UNKNOWN IMPACT ON PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240556 ↗
• MalfunctionMay 18, 2026Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED THE INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS STUCK IN STAND ALONE MODE. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207220 ↗
• MalfunctionApr 28, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT IN TO REPORT THAT THE SYSTEM WAS HAVING A HARD TIME OPENING THE GANTRY AND MAKING A LOUD NOISE WHEN OPENING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013343 ↗
• MalfunctionApr 20, 2026Mechanical 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 PENDANT BUTTONS WERE UNRESPONSIVE ON THE SYSTEM. CLINICAL SPECIALIST REPORTED THE BUTTONS WERE VERY HARD TO PUSH AND FUNCTION INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931006 ↗
• MalfunctionApr 11, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING A IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DINGUS CONTINUED TO GET MISALIGNED AND WAS CAUSING THE DOORS TO HAVE ISSUES OPENING AND CLOSING (ISSUES WITH DOOR MOVEMENT). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851773 ↗
• MalfunctionMar 25, 2026Display or Visual Feedback Problem; Poor Quality Image

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS PRODUCING SCOUT IMAGES THAT SHOWED UP AS HALF BLACKED OUT (IMAGE ISSUES). THEY ALSO NOTED THE SYSTEM WAS APPROXIMATELY 120 DAYS PAST GAIN CALIBRATION. PROBABLE CAUSE WAS POSSIBLY RELATED TO OVERDUE CALIBRATION. AS A RESOLUTION REPRESENTATIVE PERFORMED CALIBRATIONS. IF ISSUE PERSISTS, TECHNICAL SERVICE PERSON TO GENERATE QUOTE FOR SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED "FIELD SERVICE ENGINEER REPORTED THAT THIS WAS RESOLVED AFTER PERFORMING GAIN CALIBRATIONS. SINCE THE SYSTEM HAD NOT HAD ANY ISSUES AND HAD BEEN USED IN CASES. SINCE THE GAIN CALIBRATIONS WERE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688770 ↗
• MalfunctionMar 25, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S CABLE GUIDE MAY HAVE SNAPPED AND AS A PROBABLE CAUSE ISSUE MAY HAVE OCCURRED BECAUSE PINS WEREN'T ALIGNED DURING SPIN AND NAVIGATION ABORTED. 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 24685051 ↗
• MalfunctionMar 10, 2026Failure to Advance

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS A CERVICAL SPINE PROCEDURE. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES AS WELL AS NOT BEING ABLE TO USE THE IMAGING SYSTEM TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555761 ↗
• MalfunctionMar 10, 2026Mechanical Problem; Failure to Advance; Output Problem; 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 IMAGE ACQUISITION SYSTEM (IAS) WAS INTERMITTENTLY UNRESPONSIVE, AFTER CLOSING THE GANTRY AROUND THE PATIENT, SITE WERE UNABLE TO MOVE THE SUPERIOR NOR DOWNWARD. THE MEMORY BUTTON WAS ILLUMINATING WITHOUT BEING INITIATED BY ANYONE. NOTICED THAT THE DRAPES WERE GETTING SOMEWHAT CAUGHT IN THE GANTRY AND THE SITE REMOVED THEM. AS TROUBLESHOOTING STEP IAS REBOOTED, ISSUES OPENING GANTRY BUT EVENTUALLY SUCCESSFUL. ON 2ND REBOOT, THEY COULD MOVE THE SYSTEM TOWARD DOCKING BUT COULD NOT TILT NOR WAG GANTRY. SWITCHED WITH ANOTHER IAS TO COMPLETE THE CASE ISSUE NOT REPLICATED. ALLOWED THE ORIGINAL IAS TO DRAIN BATTERY, CHARGED AND BOOTED ORIGINAL BUT AGAIN COULD NOT TILT NOR WAG GANTRY 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 24554698 ↗
• MalfunctionMar 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED AND STATING THAT " THE SCREW AT T10 ON THE LEFT SIDE WAS ABOUT 7.5MM OFF. A COUPLE OTHERS WERE AROUND 5.0MM OFF.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545805 ↗
• MalfunctionMar 6, 2026Arcing; Application Program Problem; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE DOCTOR HEARD A SPARK TWICE. THEN THE SYSTEM TURNED OFF. WHEN THEY TURNED THE SYSTEM BACK ON IT ASKED FOR THEM TO DO A CALIBRATION EVEN THOUGH THEY CALIBRATED IT LAST WEEK. THEY HAD TO HOLD THE M BUTTON IT CALIBRATED AND THEN THE SYSTEM RAN FINE. THIS 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 24533019 ↗
• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  ADD INFO RECEIVED: IMAGING SYSTEM BEING USED DURING A LUMBAR SPINE PROCEDURE. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME. ADD INFO RECEIVED: THE SITE HAS DECIDED TO NOT PROCEED WITH A IMAGING SYSTEM CHECKOUT AT THAT TIME. THE SITE DECIDED THAT THE MISSING IMAGING SYSTEM TOOL CARD ON THE NAVIGATION SYSTEM WAS CAUSED BY UNTRAINED USER ERROR AND WAS THE CAUSE OF THE IMAGING AND NAVIGATION SYSTEM NOT COMMUNICATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510519 ↗
• MalfunctionMar 3, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO OPEN THE GANTRY WHILE IT WAS AROUND A PATIENT. SITE HAD ORIGINALLY CALLED FSE(FIELD SERVICE ENGINEER) WHO SUGGESTED TO FIRST USE THE GANTRY OPEN BUTTON ON THE PENDANT, THEN THE YELLOW GANTRY EMERGENCY OPEN BUTTON WITH A PENDANT BUTTON, AND THEN WITH THE WRENCH. HOWEVER, WHEN HE WAS USING THE WRENCH, HE SAID THAT IT WAS SLIPPING WHEN HE WAS TRYING TO OPEN THE GANTRY. AT THIS POINT THEY WERE UNABLE TO OPEN THE GANTRY AT ALL WHILE THE PATIENT WAS STILL IN THE O.TROUBLESHOOTING SUGGESTED THEY LIFT AND SHIFT THE GANTRY FROM AROUND THE PATIENT, AND SAITE SAID THAT THEY HAD DONE THAT ALREADY, AND BELIEVED THAT THEY WOULD BE SUCCESSFUL IN REMOVING THE PATIENT FROM THE GANTRY TABLE.SITE SAID THAT THE TWO PINS INSIDE OF THE GANTRY BY THE DOOR WERE NOT ALIGNED TO THE HOLES ON THE OTHER SIDE OF THE GANTRY DOOR. FIELD SERVICE ENGINEER HAD INSTRUCTED SITE TO REMOVE IMAGING SYSTEM COVERS TO GET A BETTER IDEA ON WHAT WAS GOING ON.SUGGESTED NOT TO TOUCH THE GANTRY FURTHER IN HOPES OF NOT CAUSING ANY FURTHER DAMAGE TO THE SYSTEM OR UNEXPECTED PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493021 ↗
• MalfunctionFeb 24, 2026Use of Device Problem; Material Deformation; Device Fell

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAS RUN INTO A WALL AGAIN AND DAMAGED THE COVERS FURTHER TO THE POINT THAT THEY FELL OFF THE SYSTEM. THE CUSTOMER ALSO NOTED THE REPRESENTATIVE HAD PREVIOUSLY ORDERED COVERS FOR THE SITE, AND THEY WERE NEVER INSTALLED, SO THERE ARE SOME COVERS AT THE SITE ALREADY WAITING TO BE INSTALLED AND ESCALATED DUE TO SYSTEM DOWN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425623 ↗
• MalfunctionFeb 22, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO OPEN. FIELD SERVICE ENGINEER WALKED THEM THROUGH THE MANUAL OPEN DOOR PROCEDURE TO BYPASS THE ISSUE INTRA-OPERATIVELY, AND THEN INVALIDATE HOME PROCESS AFTER THE CASE RESOLVED THE ISSUE. THERE WAS A REPORTED DELAY OF LESS THAN 1 HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411027 ↗
• MalfunctionFeb 20, 2026Poor Quality Image; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGE HAD BLACK-AND-WHITE INACCURACIES. IT OCCURRED INTRA OPERATIVELY AND PATIENT PRESENT AT TIME OF EVENT. TROUBLESHOOTING PERFORMED THAT THE REPRESENTATIVE HAD THE DISTRIBUTOR REBOOT THE SYSTEM UPON CALLING INTO TECHNICAL SUPPORT. RECOMMENDATIONS INCLUDED ADJUSTING BRIGHTNESS/CONTRAST SETTINGS, CHECKING RAD/GAIN CALIBRATIONS, AND PERFORMING A REBOOT. WHILE ON THE PHONE, THE REPRESENTATIVE REPORTED THAT THE ISSUE WAS RESOLVED AFTER A SECOND REBOOT. THE TEAM HAS REQUESTED AN FIELD SERVICE ENGINEER CHECKOUT. ADDITIONAL INFORMATION RECEIVED STATING THAT 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 24402789 ↗
• MalfunctionFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING SCOUT IMAGES, ALL SPINOUS PROCESS WERE IN-LINE AND WERE CENTERED MIDLINE. THEY TOOK A SCAN OF PATIENT ANATOMY FOR THE LONG SCAN AND NOTED THAT THE SCAN HAD SEEM TO SHIFT TO THE LEFT BY 5-10 CM. NO PATIENT MOVEMENT, ASPIRATIONS WERE HELD. THIS WAS OCCURRED INTRA OPERATIVELY. THERE WAS A REPORTED DELAY OF LESS THAN 1 HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331918 ↗
• MalfunctionFeb 2, 2026Failure to Advance; Power Problem; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM LOST ALL POWER AFTER BEING PLACED AROUND THE PATIENT AND THE OPEN DOOR BUTTON WAS NOT FUNCTIONING. THEY WERE UNABLE TO PERFORM A MANUAL EMERGENCY OPEN FOR AN UNKNOWN REASON. THEY WERE ABLE TO GET THE PATIENT AWAY FROM THE IMAGING SYSTEM WITHOUT DISASSEMBLING THE TABLE. THIS WAS FOR THE FINAL SPIN NO DELAY TO THE CASE. NO POWER <(>&<)> UNABLE TO OPEN. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED A NO SURGICAL DELAY. THERE WAS UNKNOWN REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232732 ↗
• MalfunctionDec 26, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM WOULD NOT OPEN. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE OCCURRED WHEN THE SITE WAS DOING A SYSTEM CHECK. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896117 ↗
• MalfunctionDec 23, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO OPEN WHEN A PATIENT WAS PRESENT. WHEN BIOMED REBOOTED THE SYSTEM AND CHECKED THE GANTRY, THE GANTRY WAS ABLE TO OPEN AND CLOSE WITHOUT ISSUE AND ABLE TO DOCK SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874447 ↗
• MalfunctionDec 19, 2025Failure to Advance; Device Sensing Problem; Noise, Audible; Application Program Freezes or Fails to Launch; Failure to Advance; Device Sensing Problem; Noise, Audible; 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 HAVING DIFFICULTY OPENING AND CLOSING. WHENEVER REPRESENTATIVE PRESSED THE OPEN OR CLOSE BUTTONS ON THE PENDANT, THE GANTRY DID NOT MOVE. AS A RESULT, PERFORMED A MANUAL OPENING OF THE SYSTEM USING THE RACHET. ONCE THE GANTRY HAD BEEN MANUALLY OPENED, THE OPEN/CLOSE BUTTONS ON THE PENDANT WORKED AGAIN. REPRESENTATIVE CLOSED THE GANTRY ALL THE WAY USING THE PENDANT BUTTON. HOWEVER, A LOUD POPPING NOISE WAS HEARD RIGHT AS THE GANTRY FULLY CLOSED. DESPITE BEING FULLY CLOSED, THE PENDANT STILL DISPLAYED A "DOOR OPEN" MESSAGE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847173 ↗
• MalfunctionDec 17, 2025Positioning Problem; Radiation Output Failure; Application Program Freezes or Fails to Launch; Positioning Problem; Radiation Output Failure; 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 STATED, DURING A CASE THIS MORNING AFTER TAKING SCOUT IMAGES, THEY WENT TO TAKE A 3D SPIN AND THE GANTRY STOPPED AND THE IAS WENT TO THE INITIALIZING SCREEN AND WOULD NOT PERFORM THE SPIN. THEY REMOVED SYSTEM FROM ROOM, AND CONTINUED CASE WITH THE OTHER O-ARM. THIS OCCURRED INTRAOPERATIVELY, AND THERE UNKNOWN DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED "THERE WAS 10 MINS OF SURGICAL DELAY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828891 ↗
• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Wireless Communication Problem; Incorrect, Inadequate or Imprecise Result or Readings; Wireless Communication Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A T11-L2 PERCUTANEOUS FIXATION PROCEDURE. IT WAS REPORTED THAT THE TRACKERS WERE INTERMITTENTLY FLICKERING AND CAUSING A POTENTIAL INACCURACY WITH THE IMAGING SYSTEM. THERE WAS A DELAY OF APPROXIMATELY TWENTY MINUTES DUE TO THE SURGEON HAVING TO TAKE FOUR DIFFERENT IMAGES FOR ONE CASE. THERE WAS NO IMPACT ON THE PATIENT, HOWEVER, THERE WAS A CONCERN OF DEFICITS PRIOR TO THE PATIENT WAKING UP FROM SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810072 ↗