O-ARM® BI70002000 (UDI 00643169980976)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169980976), received between Oct 3, 2018 and Nov 15, 2021 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM ARRIVED WITH A BROKEN X-STAGE. THE BRACKET THAT ATTACHED GANTRY TO DRIVE SCREW WAS SHEARED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814025 ↗
• MalfunctionNov 10, 2021Component Missing; Positioning Problem; Component Missing; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S MIDDLE PANELS HAD MISSING SCREWS AND THE GANTRY WAS UNABLE TO MOVE. THERE WERE NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789503 ↗
• MalfunctionNov 10, 2021Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT THE GANTRY WAS NOT OPERATIONAL; IT WAS NOT POSSIBLE TO PERFORM ANY GANTRY MOTIONS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786093 ↗
• MalfunctionSep 29, 2021Positioning Problem; Application Program Freezes or Fails to Launch; 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 SYSTEM WAS UNABLE TO INITIALIZE AND THE RADIATION WILL NOT ENABLE. THE REP REBOOTED THE SYSTEM TWICE. THEY ALSO INVALIDATED HOME BECAUSE THE SYSTEM WOULD NOT CLOSE ITS DOORS. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REP. IT WAS REPORTED THAT THE ISSUE OF THE DOORS NOT CLOSING WAS RESOLVED, BUT THE INITIALIZATION ISSUE WASN'T RESOLVED. A SYSTEM CHECKOUT WAS GOING TO BE PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REP. THE REP TOOK A LOOK AT THE SYSTEM AND DETERMINED IT NEEDS A POWER ENCLOSURE MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550236 ↗
• MalfunctionApr 22, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO SHOOT BOOSTED FLUOROSCOPIC IMAGING. IT WAS FURTHER REPORTED THAT THE MOST LIKELY CAUSE OF THE ISSUE WAS SUSPECTED TO BE DUE TO AN INTERNAL FAILURE OF THE STARTER BOARD. THE MANUFACTURER REPRESENTATIVE STATED THAT NO ADDITIONAL TROUBLESHOOTING WAS PERFORMED. IT WAS NOTED THAT THE ISSUE WAS RESOLVED WHEN SERVICING THE SYSTEM. NO PATIENT WAS PRESENT WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710061 ↗
• MalfunctionFeb 8, 2021Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WERE MULTIPLE COVERS DAMAGED ON THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11293389 ↗
• MalfunctionJan 27, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM IS NOT BOOTING UP. THE GENERATOR HAS A RED X IN THE PENDANT. TECHNICAL SERVICES HAD TRIED MULTIPLE REBOOTS AND THEY REMOTED INTO THE REMOTE DESKTOP AND EVERYTHING WAS ACTIVE AND NORMAL BESIDES THE GENERATOR NOT BEING READY. THEY CHECKED THE LOGS AND FOUND A GENERATOR ERROR 38 WHICH CORRESPONDS TO THE 5V ON PS1 BEING OUT OF RANGE. THIS WAS FOR A LAB, WITH NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11237551 ↗
• MalfunctionDec 7, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHILE BEING USED FOR MEDTRONIC DEMONSTRATIONS, THE SYSTEM'S GENERATOR WAS NOT INITIALIZING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960803 ↗
• MalfunctionSep 30, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GANTRY SHOOK WHEN IT WAS MOVED IN AND OUT. THE MOBILE VIEW STATION (MVS) WAS CONNECTING BUT THE RADIATION WAS DISABLED. THE RESOLUTION ON THE MVS ALSO LOOKED OFF.

  Patient problems: No Patient Involvement

  MAUDE report 10606345 ↗
• MalfunctionSep 22, 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 MOBILE VIEWING STATION (MVS) COMPUTER WAS NOT BOOTING. EVERY OTHER COMPONENT ON THE MVS WAS. THIS WAS REPORTED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10567944 ↗
• MalfunctionJul 31, 2020Positioning Problem; Physical Resistance/Sticking; Application Program Freezes or Fails to Launch; Positioning Problem; Physical Resistance/Sticking; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHEN THE SYSTEM WAS UNPACKED AND IT WAS NOT DOCKED, ONE OF THE PINS LOOKED BENT. WHEN STARTUP WAS ATTEMPTED, THE SYSTEM KEPT REBOOTING. WHEN ATTEMPTING TO EXTEND THE GANTRY OUT, IT WAS VERY DIFFICULT TO MOVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10352986 ↗
• MalfunctionJun 30, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE DEMO SYSTEM WAS UNCRATED AND THE MOBILE VIEWING STATION (MVS) COMPUTER IS NOT BOOTING UP. IT WAS DETERMINED THE COMPUTER WOULD NEED TO BE REPLACED. NO PATIENT PRESENT.

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

  MAUDE report 10214461 ↗
• MalfunctionFeb 25, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. DAMAGED COVERS AND DAMAGED DOCKING PINS WERE REPORTED. THIS WAS REPORTED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DAMAGE WAS DUE TO THE SYSTEM NOT BEING PROPERLY SECURED IN THE CRATE DURING SHIPPING. THE DAMAGE DID NOT AFFECT THE FUNCTIONALITY OF THE SYSTEM.

  Patient problems: No Patient Involvement

  MAUDE report 9750843 ↗
• MalfunctionDec 30, 2019Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHILE TRANSPORTING TO THE LOADING DOCK OF THE FACILITY, THE SYSTEM LOST CONTROL WHILE THE DRIVING THE SYSTEM. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SYSTEM WOULD NOT DRIVE UNDER MOTORIZED POWER, IT NEEDED TO BE IN MANUAL MODE. THE SITE WAS ABLE TO PUSH THE SYSTEM.

  Patient problems: No Patient Involvement

  MAUDE report 9531584 ↗
• MalfunctionNov 4, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO TAKE ANY IMAGES. THE SYSTEM WAS FIRST STUCK IN INITIALIZATION AND THEN WHEN IT WAS CLEARED, IT WENT INTO STANDALONE MODE. THE IMAGING SYSTEM WAS REBOOTED NUMEROUS TIMES WITHOUT RESOLUTION.

  Patient problems: No Patient Involvement

  MAUDE report 9274885 ↗
• MalfunctionApr 23, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED A CLINICAL LAB. IT WAS REPORTED THAT THE PENDANT STATED CONNECTION NOT READY, SYSTEM INITIALIZING. THIS HAPPENED MULTIPLE TIMES DURING THE COURSE OF A TWO DAY LAB ((B)(6)). THE MEDTRONIC REPRESENTATIVE WAS ABLE TO REBOOT THE SYSTEM AND CONTINUE ON THROUGH THE LAB. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. IT WAS DETERMINED THAT THE MOBILE VIEW STATION (MVS) CART NEEDS TO BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 8540341 ↗
• MalfunctionMar 11, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE KEYBOARD ON THE DEMO IMAGING SYSTEM WAS UNRESPONSIVE TO USER INPUT. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8408550 ↗
• MalfunctionMar 2, 2019Positioning Problem; Unintended Movement; Positioning Problem; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGING DEVICE LOST MOTION POWER. A MANUFACTURING REPRESENTATIVE (REP) WAS ABLE TO MANUALLY PUSH THE SYSTEM, BUT COULD NOT DO LIFT AND SHIFT TO RE-CREATE THE SYSTEM. THE MOTION BATTERIES WERE SHOWING FULL. IT WAS NOTED THAT THE SYSTEM WAS ON A CADAVER TRUCK AND THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8384701 ↗
• MalfunctionFeb 14, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PENDANT WOULD NOT POWER ON. IT WAS NOTED THAT THIS SYSTEM IS A DEMO SYSTEM AND WAS BEING USED FOR A DISPLAY; THE SYSTEM WAS BROKE WHEN IT ARRIVED FOR THE DISPLAY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8339955 ↗
• MalfunctionJan 28, 2019Failure to Power Up; Failure to Power Up

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN UN-CRATING THE IMAGING SYSTEM AT THE ACCOUNT, IT WAS FOUND THAT THE MOBILE VIEW STATION (MVS) WOULD POWER ON BUT THE IMAGE ACQUISITION SYSTEM (IAS) WOULD NOT. THE SITE STATED THAT THERE WAS NO BLUE POWER LIGHT FROM THE IAS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8282723 ↗
• MalfunctionJan 4, 2019Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE X-STAGE COVER WAS DAMAGED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8218601 ↗
• MalfunctionOct 29, 2018Failure to Run on Battery; Failure to Run on Battery

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM NEEDED NEW BATTERIES. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8015353 ↗
• MalfunctionOct 3, 2018Computer Software Problem; Device Displays Incorrect Message; Computer Software Problem; Device Displays Incorrect Message

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE VIEWING STATION OF THE IMAGING SYSTEM WOULD NOT INITIALIZE THE OPERATING SYSTEM OF THE UNIT. RESTARTING THE IMAGING SYSTEM DID NOT RESTORE FUNCTIONALITY. IT WAS NOTED THAT REMOTE DESKTOP FUNCTIONALITY COULD NOT BE PERFORMED. THE VIEWING STATION OF THE IMAGING SYSTEM WAS THEN RESTARTED WITH THE INTERFACE (UMBILICAL) CABLE CONNECTED AND AN ERROR MESSAGE APPEARED DISPLAYING "AN ERROR HAS OCCURRED THAT MAY HAVE DAMAGED THE SYSTEM'S INTEGRITY." A THIRD RESTART WAS THEN PERFORMED WITH THE INTERFACE (UMBILICAL) CABLE DISCONNECTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED AS THE SITE WAS PREPARING FOR A LAB.

  Patient problems: No Patient Involvement

  MAUDE report 7931397 ↗