O-ARM® BI70002000 (UDI 00763000355609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000355609), received between Oct 25, 2021 and Jan 29, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Mechanical Problem; Radiation Output Failure; Mechanical Problem; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PERFORM A 3D IMAGE THERE WAS HANDSWITCH ISSUES. DURING A SYSTEM CHECK IT WAS NOT POSSIBLE TO PERFORM 3D IMAGES HOWEVER 2D IMAGES WERE POSSIBLE. BY PROVIDING PHONE SUPPORT IT WAS FOUND THAT THE MIDDLE BUTTON OF THE HANDSWITCHWAS NOT FUNCTIONING AND THEREFORE NEEDED TO BE REPLACED. THE SYSTEM WAS FULLY FUNCTIONAL WITH THE FOOTSWITCH. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THE HANDSWITCH. THE NEXT STEP WAS TO REPLACE THE HANDSWITCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269002 ↗
• MalfunctionNov 29, 2024Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT COULD NOT SHOOT X-RAY FROM HAND SWITCH. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808943 ↗
• MalfunctionSep 22, 2022Physical Resistance/Sticking; Application Program Freezes or Fails to Launch; Physical Resistance/Sticking; 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 A SYSTEM CHECK, THE SYSTEM WAS UNABLE TO TAKE 3D IMAGES BUT 2D WAS FINE. THE IMAGE ACQUISITION SYSTEM (IAS) WAS REBOOTED AND THE HAND-SWITCH WAS TESTED AND IT COULD NOT TAKE A 3D IMAGE. THE FOOT SWITCH WAS TESTED AND IT WAS WORKING FINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462357 ↗
• MalfunctionAug 22, 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 IMAGE ACQUISITION SYSTEM (IAS) WAS NOT BOOTING UP, AS THE TOP BAR WAS SCROLLING AND A RED "X" WAS DISPLAYED ON THE NEXT TWO BARS.  TROUBLESHOOTING STEPS WERE PERFORMED, WHICH SHOWED THAT THERE WAS AN ISSUE WITH THE UMBILICAL CABLE.  THE SITE TRIED TO CONNECT TO THE REMOTE DESKTOP BUT IT WAS NOT POSSIBLE.  IT WAS NOTED THAT THE PROBABLE CAUSE WAS SUSPECTED TO BE DUE TO THE COMPUTER OR POWER ENCLOSURE, AND THE UMBILICAL CABLE WAS TO BE REPLACED.  NO PATIENT WAS PRESENT WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266443 ↗
• MalfunctionOct 25, 2021Device Sensing Problem; Device Sensing Problem

  CONFLICTING INFORMATION WAS RECEIVED. IT WAS REPORTED, THAT NO PATIENT WAS PRESENT, AND THAT THERE WAS NO IMPACT TO THE PATIENT. IT WAS UNCLEAR WHETHER, OR NOT A PATIENT WAS PRESENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12691611 ↗