O-arm O2 BI70002000 (UDI 00763000863302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000863302), received between Sep 26, 2024 and May 28, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 reports).

1 FDA recall record 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SITE WAS SEEING ARTIFACT IN THEIR 2D AND 3D SCANS. SITE REBOOTED AND TOOK ADDITIONAL SCANS AND NO LONGER SAW THE ARTIFACT. UNKNOWN WHEN RAD GAIN CALIBRATIONS COMPLETED LAST. PATIENT PRESENCE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316016 ↗
• MalfunctionMay 28, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS A LARGE WHITE ARTIFACT ON 3D IMAGING. AND WAS UNSURE IF THIS WAS ALSO PRESENT ON 2D IMAGES. ADDITIONAL INFORMATION STATING THAT "THE PROCEDURE BEING PERFORMED WHEN THE EVENT OCCURRED WAS A POSTERIOR CERVICAL FUSION. THE PATIENT OUTCOME WAS UNIMPACTED BY THE EVENT. THE EVENT CAUSED ABOUT A 15-MINUTE DELAY IN THE CASE WHILE THEY SWITCHED TO A DIFFERENT IMAGING SYSTEM AND PERFORMED ANOTHER SCAN. THE ISSUE OCCURRED INTRA-OP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315859 ↗
• MalfunctionMay 19, 2026Radiation Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT REPORT A SECOND OCCURRENCE OF AN IMAGING ISSUE FIRST REPORTED ON ANOTHER CASE. FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE ISSUE HAD BEEN TRACED BACK TO A BAD ASIC ON THE DETECTOR PANEL. THERE WAS A PATIENT PRESENT. 2025-NOV-14 E1 (REP): ADDITIONAL INFORMATION RECEIVED. IT WAS OCCURRED OUTSIDE OF PROCEDURE AND OCCURRED PRE OPERATIVELY. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216690 ↗
• MalfunctionJan 28, 2026Mechanical Problem; Unintended System Motion; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED REGARDING DRIVE ISSUES THAT THE SYSTEM WAS NOT DRIVING AS INTENDED WITH THE CLUTCH MOTOR ENGAGED. IMAGING SYSTEM PULLS TO THE RIGHT AND GIVES RESISTANCE AND PULLING IT BACK CAUSES IT TO MOVE BACK VERY FAST. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196901 ↗
• MalfunctionNov 28, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Device Fell; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Device Fell

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED REGARDING LOOSE GANTRY PIECE AND THERE WAS A PIECE OF THE INNER GANTRY THAT HAS FALLEN OUT OF THE SYSTEM. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669281 ↗
• MalfunctionOct 23, 2025Failure to Advance; Positioning Problem; Application Program Freezes or Fails to Launch; Failure to Advance; Positioning 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 GANTRY WAS UNABLE TO DOCK. SITE ATTEMPTED TO INVALIDATE HOME, HOWEVER THE GANTRY WOULD NOT PROCEED PAST THE LEFT TILTED POSITION. REPRESENTATIVE CONFIRMED WITH THE SITE THAT HE WAS ABLE TO MOVE THE GANTRY IN DIFFERENT POSITIONS, HOWEVER HE ALSO REPORTED THAT THE "DOOR OPEN" BUTTON ON THE PENDANT WAS UNRESPONSIVE. IMAGING SYSTEM FULLY EXTENDED AND WAS NOT ABLE TO BRING IT BACK INTO THE HOME POSITION. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364750 ↗
• MalfunctionJul 28, 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 A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS STUCK IN INITIALIZING UPON BOOT UP, AFTER REBOOTING THE ISSUE RESOLVED AND THEY PROCEEDED TO USE THE SYSTEM. LATER DURING THE CASE, THE GANTRY WOULD THEN NOT OPEN AND WAS STUCK AROUND THE PATIENT.  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 22630336 ↗
• MalfunctionJul 25, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ARM WON'T OPEN. REPRESENTATIVE ATTEMPTED TO MANUALLY OPEN THE ARM WITH THE CRANK BUT THE DOOR WOULD NOT OPEN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606271 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE UNIT WAS HAVING DIFFICULTY OPENING AND CLOSING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385153 ↗
• MalfunctionJul 2, 2025Mechanical Problem; Failure to Advance; Noise, Audible; Mechanical Problem; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE DURING A CASE, THE GANTRY DOORS WERE MAKING A LOUD NOISE AND GOT STUCK AROUND THE PATIENT. SITE HAD TO MANUALLY OPEN THEM. THE DOOR WOULD NOT OPEN. MANUFACTURING REPRESENTATIVE(REP) WALKED THEM THROUGH THE YELLOW BUTTON EMERGENCY OVERRIDE. REP WAS UNKNOWN THROUGH DOOR OPENING PROCEDURE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384510 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT GANTRY WILL NOT OPEN. AS A TROUBLESHOOTING STEP, REPRESENTATIVE MANUALLY REHOMED ROTOR, AND INVALIDATED HOME AND IT RESOLVED THE ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383168 ↗
• MalfunctionJun 30, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER REMOVING THE SYSTEM FROM THE CRATE, THE GANTRY WOULD NOT OPEN AND THE ROTOR WOULD NOT MOVE.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356171 ↗
• MalfunctionJun 27, 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 DOOR WAS GETTING STUCK WHEN OPENING/CLOSING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343234 ↗
• MalfunctionMay 29, 2025Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE 2DLF ACQUISITION STOPPED HALFWAY THROUGH THE SCAN. ADDITIONAL PROCEDURAL ISSUES INCLUDED THE SYSTEM NOT ALLOWING A 2DLF WITH PRESETS ON THE Z AXIS EXTREMITIES AND THE RADIOLOGIC TECHNOLOGIST NOT RETURNING THE GANTRY TO PRESET 1 DURING THE INITIAL FAILED SCAN. MECHANICAL INSPECTION, IMAGING MODALITIES CHECK, CABLE GRADE CHECK, INSPECTION AND OPERATIONAL TESTS, AND A SYSTEM CHECKOUT AS PER USER MANUAL GUIDELINES AND CHECKLIST WERE CONDUCTED, ALL OF WHICH PASSED. MULTIPLE 2DLF SCANS WITH PRESETTING ON THE Z EXTREMITIES WERE PERFORMED SUCCESSFULLY AFTER RE-HOMING THE AXIS. PATIENT WAS PRESENT. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105190 ↗
• MalfunctionApr 4, 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 BUTTONS WERE ALLEGEDLY UNRESPONSIVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770941 ↗
• MalfunctionApr 3, 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 AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT WHILE PREPARING TO TAKE 2D SHOTS, THE IMAGE ACQUISITION SYSTEM (IAS) PENDANT UNEXPECTEDLY DISPLAYED "INITIALIZING SYSTEM, PLEASE WAIT." SITE REBOOT THE SYSTEM. THE SITE DISCONNECTED THE IAS AND MOBILE VIEW STATION (MVS) AND POWERED EACH ON INDEPENDENTLY. SITE RECONNECT THE IAS AND MVS ONCE BOTH WERE POWERED ON ALL THE WAY. THE IAS PENDANT SWITCHED FROM "INITIALIZING PLEASE WAIT" TO "STANDALONE MODE." AFTER ABOUT A MINUTE, THE STANDALONE MODE MESSAGE CLEARED AND THE PENDANT INDICATED THE SYSTEM WAS READY TO TAKE 2D SHOTS. THE SITE HAD ALREADY PROCEEDED WITH THE CASE BY THIS POINT, BUT STILL PLANNED TO USE THE SYSTEM FOR CONFIRMATION SHOTS AT THE END OF SURGERY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759830 ↗
• MalfunctionFeb 24, 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO TAKE A SPIN WHILE IN SURGERY. THE LOADING BAR ON THE MVS (MOBILE VIEWING STATION) FILLED UP AFTER CLICKING THE HANDSWITCH, BUT THE SYSTEM DID NOT PROGRESS PAST. SYSTEM DID NOT TAKE THE SPIN. SITE WAS THEN ABLE TO CONTINUE WITH TAKING A SPIN AFTER THE SYSTEM WAS REBOOTED. 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 21443060 ↗
• MalfunctionJan 29, 2025Audible Prompt/Feedback Problem; Radiation Output Failure; Application Program Freezes or Fails to Launch; Audible Prompt/Feedback 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 SITE WAS UNABLE TO TAKE A SPIN WHILE IN SURGERY. AFTER HOLDING THE BUTTON ON THE HANDSWTICH THE LOADING BAR ON THE MOBILE VIEWING STATION (MVS) FILLED UP, BUT THE SYSTEM DID NOT PROGRESS PAST. SYSTEM DID NOT BEEP OR TAKE THE SPIN. THE LIGHT ON THE MVS CONTINUED TO FLASH GREEN. SITE TRIED RELEASING THE HANDSWITCH AND TRYING AGAIN WITH NO CHANGE. SYSTEM WAS REMOVED FROM AROUND PATIENT AND REBOOTED. SITE WAS THEN ABLE TO CONTINUE WITH TAKING A SPIN. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED 10 MINUTES SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264343 ↗
• MalfunctionJan 8, 2025Mechanical Problem; Unintended System Motion; Mechanical Problem; Unintended System Motion

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS INTERMITTENTLY HAVING DRIVE ISSUES AND WHEN PUSHED OVERRIDE BREAK AND CLUTCH WITH NO RESOLUTION. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099711 ↗
• MalfunctionJan 2, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM IS UNABLE TO TAKE SCANS. CALLER DID NOT HAVE ANY FURTHER DETAILS. TS CALLED POC AND HE WAS NOT THERE BUT UNKNOWN PICKED UP AND HE REPORTED SOUNDS LIKE WHEN PLUGGED IN, THE MONITOR PORTION BEEPS, STILL WORKS AND TAKES SCANS. SOMEONE LOOKED AT IT AND IT MIGHT BE THE GENERATOR. HE DID NOT KNOW THE SERIAL NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054771 ↗
• MalfunctionDec 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L5 AND S1, IMAGES WERE TRANSFERRED FROM THE IMAGING SYSTEM AND CORRECTLY SET UP ON THE MOBILE VIEWING STATION (MVS). WHILE NAVIGATING THE S1 VERTEBRAE, THEY STATED THE S1 VERTEBRAE APPEARED TO HAVE OVERLAPPING SLICES. THEY CONFIRMED THE REST OF THE IMAGE IS CLEAR. SPIN WAS TAKEN WITH THE PATIENT'S ARMS KEPT AT THE SIDE OF THE PATIENT'S BODY. IN TROUBLESHOOTING THE REP RECOMMENDED TAKING ANOTHER SPIN IF SURGERY ALLOWED, OPENING THE IMAGE ANNOTATION ON THE MOBILE VIEWING STATION (MVS) AND ADJUSTING THE IMAGE'S BRIGHTNESS/CONTRAST AND SEE IF THE IMAGE WAS ABLE TO BE MANIPULATED CORRECTLY. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916062 ↗
• MalfunctionDec 6, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT PENDANT WAS INDICATING THAT THE DOOR WAS ALWAYS OPEN EVEN THOUGH IT WAS CLOSED. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861353 ↗
• MalfunctionNov 1, 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 DURING A PROCEDURE, THE SITE ACQUIRED TWO 3D LF (LONG FILM) (PRE AND POST) AND AFTER EACH SCAN, WHEN PRESSING THE GANTRY MOVEMENT BUTTONS ON THE PENDANT, THE GANTRY WOULD NOT MOVE IN ANY DIRECTION. THEY HAD TO RAISE THE BED TO REMOVE PATIENT. THE MANUFACTURER REPRESENTATIVE (CC) REPORTED AFTER ABOUT "5 MINUTES" WITHOUT ANYTHING FURTHER DONE TO SYSTEM, THE GANTRY BUTTONS STARTED WORKING EACH TIME. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME, AND NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593673 ↗
• MalfunctionNov 1, 2024Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS CLOSED AROUND A PATIENT AND NOT OPENING. THERE WAS PATIENT PRESENT DURING THE EVENT AND ONE HOUR OR MORE THAN ONE HOUR OF SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585659 ↗
• MalfunctionOct 23, 2024Application 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 GRAYED OUT UPON BOOT UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514417 ↗