O-ARM® BI70002000 (UDI 00763000355555)Recalls & reported problems

Summary

The FDA's MAUDE database contains 811 adverse event reports that list this exact device (DI 00763000355555), received between Nov 6, 2020 and Sep 25, 2026 — classified as 1 death, 2 injuries, 808 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (307 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 811 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Display or Visual Feedback Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899325 ↗
• MalfunctionApr 1, 2026Mechanical Problem; Failure to Advance; Device Sensing Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WOULD NOT OPEN. THE RADIOLOGY TECHNICIAN HAD DONE THEIR NORMAL CHECKOUT WITH THE SYSTEM AND FOUND THAT AFTER THEY HAD CLOSED THE SYSTEM IT WOULD NOT DETECT THAT IT WAS CLOSED AND THEN WOULD NOT OPEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION STATING THAT THE SITE WHILE IN FRONT OF THE SYSTEM TO TRIED TO TROUBLESHOOT THE UNRESPONSIVE DOOR. SITE REPORTED THAT DOOR WOULD NOT OPEN OR CLOSE, EVEN WITH THE EMERGENCY YELLOW BUTTON. DOOR WAS STUCK APPROXIMATELY A QUARTER INCH FROM FULLY CLOSED. SITE REPORTED THAT THEY HAD ATTEMPTED TO REBOOT SYSTEM 3 TIMES BEFORE REPORTING THE ISSUE. GANTRY WAS ABLE TO MOVE UP AND DOWN AND SIDE TO SIDE, BUT DID NOT RESPOND TO DOCKING BUTTON. PENDANT MESSAGE DISPLAYED "DOOR OPEN." TECHNICAL SPECIALIST (TS) ATTEMPTED TO REBOOT IMAGE ACQUISITION SYSTEM (IAS) AND UNPLUGGING UMBILICAL CABLE UNTIL IAS WAS FULLY BOOTED UP. THAT WAS COMPLETED, BUT DOOR WAS STILL UNRESPONSIVE. THE ROTOR MISALIGNED AND JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755115 ↗
• MalfunctionMar 26, 2026Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN OPENING THE GANTRY DOORS THEY WERE STICKING AND NOT OPENING SMOOTHLY. ALSO, MADE A POPPING SOUND AS THAT OPEN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696511 ↗
• MalfunctionFeb 2, 2026Failure to Advance; Device Fell

  PICTURE OF THE BLACK PLASTIC WAS NOT FROM THE IMAGING SYSTEM. REPRESENTATIVE REPORTED THAT THEY DID A SPIN AND CONFIRMED THAT NOTHING APPEARED, NO NOISES, MALFUNCTION AND SYSTEM WAS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235309 ↗
• MalfunctionJan 13, 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 SYSTEM DID NOT FULLY BOOT AND REMAINED STUCK IN INITIALIZATION. THE FIELD SERVICE ENGINEER DETERMINED THAT THE SYSTEM REQUIRED A NEW STANDALONE BOARD. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE IMAGING ACQUISITION SYSTEM (IAS) DID NOT FULLY BOOT AND REMAINED STUCK IN INITIALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053065 ↗
• MalfunctionDec 18, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM GANTRY WOULD NOT OPEN WHEN THE OPEN BUTTON ON THE PENDANT WAS PRESSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839619 ↗
• MalfunctionNov 24, 2025Failure to Advance; Failure to Advance

  (B)(6) 2025. E1 REP: NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630469 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device; Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED. IT WAS OCCURRED INTRA OPERATIVELY, THERE WAS A REPORTED DELAY OF 30 MINUTES AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615939 ↗
• MalfunctionNov 10, 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SITE CAN'T OPEN OR CLOSE THE GANTRY WITHOUT IT "INTERFERING WITH THE MONITOR" AS UNKNOWN MONITOR ISSUES. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507714 ↗
• MalfunctionNov 4, 2025Use of Device Problem; Failure to Advance; Positioning Problem; Use of Device Problem; Failure to Advance; Positioning Problem

  ADDITIONAL INFORMATION RECEIVED "DURING COMPLETION OF A POSTERIOR LUMBAR INTERBODY FUSION SYSTEM FAILED TO OPEN. EMERGENCY PROCEDURES WERE INITIATED TOO MANUALLY OPEN THE GANTRY. THE PATIENT WAS UNCONSCIOUS UNDER ANESTHESIA AT THE TIME. THE PATIENT WAS STUCK ON THE SURGERY TABLE UNTIL THE GANTRY COULD BE OPENED. THIS CAUSED THE PATIENT TO REMAIN UNDER ANESTHESIA FOR AN EXTRA 20-30 MINS BEFORE THE GANTRY WAS OPEN AND THE PATIENT COULD SAFELY BE MOVED. DELAY IN CARE, EXCESSIVE ANESTHESIA. THE GANTRY FAILED TO DOCK DESPITE MULTIPLE ATTEMPTS AND RESETS. THE CONTROL PANEL WAS SLUGGISH OR DID NOT RESPOND TO COMMANDS. WE WERE NOT ABLE TO USE IT WITH ANY CONFIDENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463894 ↗
• MalfunctionOct 31, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT A 3D SPIN COMPLETED, BUT INITIALLY APPEARED CROPPED. AFTER THE 3D SPIN WAS TAKEN, THE IMAGE THAT APPEARED ON THE MVS LOOKED CROPPED. SURGICAL TEAM EXITED OUT OF IMAGE AND REOPENED IT. WHEN REOPENED, THE FULL IMAGE APPEARED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434450 ↗
• MalfunctionOct 28, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DOOR WAS STUCK AND THE DOORS ARE UNABLE TO OPEN OR CLOSE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400111 ↗
• MalfunctionOct 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT A 2DLF IMAGE APPEARED CROPPED EVEN THOUGH THE SCOUT SCAN TAKEN AT THE SAME POSITION APPEARED TO SHOW THE ENTIRE DESIRED FIELD OF VIEW. CC REPORTED THAT THERE WAS A FRACTION OF THE IMAGE THAT WAS CUT OFF ON THE 2DLF THAT WAS PRESENT ON THE SCOUT IMAGE (2DLF CROPPED IMAGE). TROUBLESHOOTING, TS SUGGESTED PERFORMING GAIN CALIBRATION AND ENSURING THAT COLLIMATOR WAS FULLY OPENED. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED "SCOLIOSIS T5-L4 PROCEDURE INVOLVED. ISSUE OCCURRED INTRA-OPERATIVELY AND NO IMPACT ON PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322577 ↗
• MalfunctionOct 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED "IT WAS OFF BY A COUPLE MM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23192352 ↗
• MalfunctionSep 2, 2025Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS ISSUE ORIGINATED DUE TO USER ERROR. THE BUTTON TO OPEN THE SYSTEM NEEDS TO BE HELD, BUT THE RADIOLOGY TECHNICIAN WAS JUST PRESSING THE BUTTON RATHER THAN HOLDING IT DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935817 ↗
• MalfunctionAug 29, 2025Failure to Advance; Noise, Audible; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM GANTRY WAS EXPERIENCING A SERIES OF ISSUES. WHILE PERFORMING A 3D SPIN, THE SITE REPORTED THAT THE SYSTEM WAS LOUDER THAN NORMAL, PARTICULARLY AROUND THE COLLIMATOR. ADDITIONALLY, THE SYSTEM GANTRY GOT STUCK AROUND A PATIENT, AND THE SITE WAS UNABLE TO OPEN THE GANTRY VIA THE PENDANT BUTTONS. AS A RESULT, THE SITE PERFORMED A PARTIAL SYSTEM OPEN VIA THE RATCHET, THEN OPENED THE GANTRY NORMALLY THE REST OF THE WAY. THIS HAD OCCURRED INTRA OPERATIVELY. THERE WAS A PATIENT PRESENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920879 ↗
• MalfunctionAug 29, 2025Mechanical Problem; Failure to Advance; Application Program Freezes or Fails to Launch; Mechanical Problem; Failure to Advance; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SYSTEM DOOR MOVEMENT WAS UNRESPONSIVE AND THE DOOR WAS UNABLE TO OPEN WITH DOOR BUTTON ON PENDANT. REPRESENTATIVE USED EMERGENCY YELLOW BUTTON AND CLOSE BUTTON TO ACTIVATE THE DOOR. AFTER THAT, DID NOT RECEIVE ANY MORE CALLS, SO IT COULD HAVE ONLY OCCURRED ONCE. ISSUE WAS REPORTED DURING SETUP FOR CASE. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920520 ↗
• MalfunctionAug 28, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT COULD NOT DUPLICATE ISSUE BUT NOTICED PENDANT BUTTONS WERE HARD TO PUSH AND HAND SWITCH BUTTONS ALSO INCONSISTENT. REPLACED CONTROL PENDANT AND HAND SWITCH. ALL TESTING WERE PASSED. 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 22913803 ↗
• MalfunctionAug 14, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Poor Quality Image; Application Program Problem; Display or Visual Feedback Problem; Image Display Error/Artifact; Poor Quality Image; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN USING FOV (FIELD OF VIEW), THEY RECEIVED AN ERROR THAT "CAN'T BE VIEWED WITH A ROTATED IMAGE, NEEDED TO SET TO 0.THE REPRESENTATIVE REBOOTED AND THEN ABLE TO USE FOV BUT IMAGES WERE BLACK (UNABLE TO SEE SCREWS OR BONE.) REPRESENTATIVE REBOOTED AGAIN AND IMAGES "WERE BETTER" BUT HAD ARTIFACT IN THEM. THEY PROCEEDED WITH THE CASE USING THE SCANS. 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 22801845 ↗
• MalfunctionAug 13, 2025Unintended System Motion; Adverse Event Without Identified Device or Use Problem; Unintended System Motion; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS AGGRESSIVELY DRIVING BACKWARDS. THEY STATED IT WAS DRIVING SIMILARLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791338 ↗
• MalfunctionJul 30, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT DURING A CASE, WHEN ATTEMPTING TO PRESS LEFT ON THE PENDANT, THE SYSTEM PERFORMED A TILT. THIS ISSUE OCCURRED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666868 ↗
• MalfunctionJul 30, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR GOT STUCK CLOSED AROUND A PATIENT. SITE WAS ABLE TO USE THE CRANK TO OPEN THE DOOR AND REMOVE 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 22663541 ↗
• MalfunctionJul 29, 2025Failure to Advance; Positioning Problem; Failure to Advance; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR WAS STUCK CLOSED. SITE ATTEMPTED TO USE THE OVERRIDE BUTTON TO OPEN IT BUT THEY WERE UNSUCCESSFUL. DOOR IS CURRENTLY STUCK CLOSED. REPRESENTATIVE ALSO REPORTED THAT THE SYSTEM WAS NOT DOCKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641365 ↗
• MalfunctionJul 28, 2025Failure to Advance; Noise, Audible; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS NOISE IN THE GANTRY. IT ALSO GOT STUCK OVER THE PATIENT AND THEY HAD TO USE THE EMERGENCY DOOR OPEN PROCEDURE TO OPEN THE SYSTEM. THIS HAPPENED AT THE END OF THE CASE WHEN THEY HAD DONE THERE LAST SPIN. THIS ISSUE OCCURRED POST OPERATIVELY AND CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628395 ↗
• MalfunctionJul 25, 2025Unintended Electrical Shock; Unintended Electrical Shock

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT EXPOSED GANTRY CABLES WERE NOTED. NO ERROR MESSAGES APPEARED, AND THE SYSTEM APPEARED TO BE FUNCTIONING AS INTENDED. THE SITE REQUESTED A SYSTEM CHECKOUT. PATIENT PRESENCE AT THE TIME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609174 ↗