O-ARM® BI70000028120 (UDI 00643169845091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169845091), received between May 15, 2018 and Sep 5, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (5 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS RECEIVING 'ERROR INITIALIZING COLLIMATOR' WHEN THEY WERE BOOTING UP THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145951 ↗
• MalfunctionJul 7, 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 MOBILE VIEW STATION (MVS) COMPUTER HAD BEEN SHUTTING DOWN AND REBOOTING INTERMITTENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686743 ↗
• MalfunctionJun 13, 2024Failure to Align; Radiation Output Failure; Failure to Align; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS CURRENTLY UNABLE TO PERFORM A SPIN DUE TO THE GREEN LIGHT GOING IN AND OUT INTERMITTENTLY. THE LIGHT WAS FLASHING TOO FAST TO BE ABLE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529558 ↗
• MalfunctionJul 28, 2022Application 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 DURING PLANNED MAINTENANCE (PM) IT WAS DISCOVERED THAT THIS SYSTEM EXPERIENCED OCCASIONAL FRAME RATE ERRORS DURING SPINS/EXPOSURES. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121704 ↗
• MalfunctionMar 29, 2022Application 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 IMAGING ACQUISITION SYSTEM (IAS) WOULD OCCASIONALLY SWITCH INTO STAND-ALONE MODE WHEN IN USE. THE ISSUE DISCOVERED OUTSIDE OF CASE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939424 ↗
• MalfunctionNov 12, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WAS STUCK IN "SYSTEM BOOTING PLEASE WAIT" WHILE TRYING TO BOOT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10829339 ↗
• MalfunctionNov 24, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE IMAGING SYSTEM DISPLAYED A COLLIMATOR INITIALIZATION ERROR AT START UP. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9367275 ↗
• MalfunctionAug 6, 2019Failure to Power Up; Failure to Power Up

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S UPS IS NOT HOLDING CHARGE. THIS HAS BEEN GOING ON FOR AN EXTENDED PERIOD OF TIME. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8865765 ↗
• MalfunctionAug 5, 2019Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE SELECT PATIENT/ACQUIRE SCANS TASK OF A SACROILIAC AND THORACOLUMBAR PROCEDURE THERE WAS A MOBILE VIEW STATION (MVS) AND IMAGE ACQUISITION SYSTEM (IAS) SHUT DOWN WHILE SETTING UP FOR A 3D SPIN. REBOOTING BOTH SYSTEMS FIXED THIS ISSUE AND THE SITE WAS ABLE TO PROCEED WITH THE CASE. IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO ONE ADDITIONAL IMAGING SPIN. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8861309 ↗
• MalfunctionSep 21, 2018Poor Quality Image; Poor Quality Image

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE SELECT PATIENT/ACQUIRE SCANS TASK OF A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE 2D IMAGES WERE LIGHT/WASHED OUT AND KV WAS AT 70, AND THE 3D SCAN WAS BLACK. NAVIGATION WAS ABORTED FOR THE PROCEDURE, AND A DIFFERENT IMAGING SYSTEM WAS BROUGHT IN. NO TROUBLESHOOTING PREFORMED BY THE SITE. REQUESTED A SITE VISIT. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7897573 ↗
• MalfunctionSep 19, 2018Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TRACKER IS NOT RECOGNIZED BY THE IGS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7890012 ↗
• MalfunctionAug 23, 2018Poor Quality Image; Poor Quality Image

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE SELECT PATIENT/ACQUIRE SCANS TASK OF A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE 2D IMAGE QUALITY WAS GRAYED OUT DURING A CASE. THE SITE WAS SUSPECTING AUTO-BRIGHTNESS NOT WORKING AND WILL REINSTALL SOFTWARE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810277 ↗
• MalfunctionAug 23, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT AFTER THE CASE THE SYSTEM WAS BEING MOVED OUT OF THE OR AND THE MOBILE VIEWING STATION (MVS) STARTED BEEPING. AN ERROR MESSAGE APPEARED REGARDING THE LINE POWER LIGHT. THE BATTERIES WERE NOT SHOWING THAT THEY WERE CHARGING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7809279 ↗
• MalfunctionAug 7, 2018Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MOBILE VIEW STATION (MVS) WAS SHOWING THE ERROR "IMAGE FRAME RATES BELOW RECOMMENDED LEVELS, PLEASE RECONNECT CABLE BETWEEN [IMAGING SYSTEM] AND MVS AND REBOOT MVS." SEVERAL RESTARTS DID NOT FIX THE ISSUE. UMBILICAL REPORTED AS NOT GROSSLY DEFORMED BUT VERY HIGH USE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7757962 ↗
• MalfunctionJun 22, 2018Bent; Bent

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE. IT WAS REPORTED THAT THE X-STAGE COVER WAS DAMAGED. THIS WAS OBSERVED OUTSIDE OF A SURGICAL PROCEDURE. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7631547 ↗
• MalfunctionJun 15, 2018Electrical /Electronic Property Problem; Device Operates Differently Than Expected; Electrical /Electronic Property Problem; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE. IT WAS REPORTED THAT THE DEVICE WON¿T TURN ON. THE SITE FURTHER REPORTED THAT THE OUTLET HAD BLOWN A FUSE WHICH CAUSED THE MOBILE VIEW STATION¿S (MVS) BATTERY TO DEPLETE. THE DEVICE WAS PLUGGED INTO A KNOWN GOOD OUTLET AND THE ISSUE WAS RESOLVED. THIS WAS OBSERVED OUTSIDE OF A SURGICAL PROCEDURE. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7607415 ↗
• MalfunctionJun 12, 2018No Display/Image; Device Operates Differently Than Expected; No Display/Image; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE. IT WAS REPORTED INTRAOPERATIVELY THAT THE MOBILE VIEW STATION (MVS) KEPT SHUTTING DOWN AND GOING COMPLETELY BLACK BYPASSING ALL THE SHUTDOWN SEQUENCES WHILE INPUTTING PATIENT INFORMATION. THE SITE PLUGGED THE MVS INTO A DIFFERENT OUTLET AND THE ISSUE WAS RESOLVED. THE SURGICAL DELAY WAS LESS THAN ONE HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594280 ↗
• MalfunctionMay 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED INFORMATION THAT THE MOBILE VIEW STATION (MVS) TURNS OFF IMMEDIATELY AFTER BEING UNPLUGGED FROM THE WALL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7530212 ↗
• MalfunctionMay 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MOBILE VIEWING STATION WAS NOT POWERING ON. THE ISSUE OCCURRED WHILE UPGRADING THE SOFTWARE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7515606 ↗