O-arm BI70002000 (UDI 00643169618121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169618121), received between Oct 21, 2024 and Sep 29, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Medtronic received information regarding an imaging system being used in an unknown procedure. It was reported that there was a navigation inaccuracy in connection with the imaging system. Patient presence was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928083 ↗
• 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 THERE WAS A DOOR CLOSING PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384923 ↗
• MalfunctionJun 25, 2025Poor Quality Image; Failure to Advance; Poor Quality Image; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE DOOR WAS UNABLE TO BE OPENED VIA THE PENDANT. THE MECHANICAL DOOR OPENING ALSO DID NOT WORK. THE SITE THEN MANAGED TO GET THE PATIENT OUT OF THE IMAGING SYSTEM BY MOVING THE SURGICAL TABLE AND OPENING THE CLUTCH OF THE SYSTEM TO DISENGAGE THE WHEEL BRAKES. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE THAN 1 HOUR DUE TO THIS ISSUE. ADDITIONAL INFORMATION WAS RECEIVED. THE SURGEON SAID THAT THE IMAGE QUALITY WAS VERY BAD AND THE SURGERY WAS HARD TO PERFORM DUE TO THIS. THE SURGERY WAS A PELVIC FUSION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327171 ↗
• MalfunctionJun 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 DOOR COULD NOT BE CLOSED OR OPENED PER THE PENDANT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326811 ↗
• MalfunctionJun 24, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE USER HAD DIFFICULTY OPENING THE DOOR. THE DOOR COULD ONLY BE OPENED BY MANUALLY ASSISTING AND LIFTING ONE OF THE SIDE DOOR COVERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322841 ↗
• MalfunctionMay 13, 2025Power Problem; Noise, Audible; Radiation Output Failure; Power Problem; Noise, Audible; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM WAS BEEPING WHICH WAS COMING FROM THE GENERATOR. THERE WAS ALSO NO X-RAY POSSIBLE. IN THE LOGS, IT WAS OBSERVED THAT THE 5V POWER SUPPLY WAS DRIFTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013659 ↗
• MalfunctionMay 5, 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PENDANT BUTTONS WERE HARD TO PRESS AND 2D LONG FILM WAS NOT POSSIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961224 ↗
• MalfunctionApr 30, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT READINESS FOR RADIATION TEMPORARILY WAS NOT POSSIBLE. NO KNOWN IMPACT TO PATIENT OUTCOME. SURGICAL DELAY NOT PROVIDED, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933649 ↗
• MalfunctionMar 13, 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 A PROCEDURE. IT WAS REPORTED THAT THE 3D-SCAN DID NOT WORK THROUGH HAND SWITCH. 3D-SCAN THROUGH FOOT SWITCH WORKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596250 ↗
• MalfunctionMar 10, 2025Noise, Audible; Application Program Freezes or Fails to Launch; Noise, Audible; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT IT WAS DIFFICULT TO SCAN AND THE SYSTEM WAS BEEPING. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE SUCCEEDED IN TAKING A SCAN AFTER REBOOTING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561983 ↗
• MalfunctionJan 31, 2025Noise, Audible; Application Program Freezes or Fails to Launch; Noise, Audible; 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 BEEPING AND NO X-RAY AVAILABLE. AFTER REBOOT, THE SYSTEM WAS WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287393 ↗
• 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 THE 3D SCAN BUTTON ON THE HAND SWITCH WAS NOT WORKING. IT WAS NOT POSSIBLE TO START A 3D SCAN, BUT 2D WORKED. THE FOOTSWITCH WAS WORKING FINE WITH 2D AND 3D SCANS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268054 ↗
• MalfunctionJan 27, 2025Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO START A 3D SCAN. 2D WAS WORKING WITHOUT PROBLEMS. A SYSTEM RESTART DID NOT SOLVE THIS ISSUE. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS A DEFECTIVE HAND SWITCH BUTTON. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241513 ↗
• MalfunctionJan 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT 2D WAS SPORADIC/NOT POSSIBLE. AFTER REBOOTING THE SYSTEM, IT WAS WORKING. THE ERROR LOG SHOWED GENERATOR ERROR 164. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229559 ↗
• MalfunctionDec 3, 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 BUTTONS WERE SOMETIMES UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835985 ↗
• MalfunctionNov 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING A SERVICE ACTION, THE MANUFACTURER REPRESENTATIVE (REP) DETECTED AN INACCURACY IN NAVIGATION. THE INACCURACY WAS WITH THE NAVIGATED 3D SCAN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593036 ↗
• MalfunctionOct 21, 2024Radiation Output Problem; Radiation Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE BEING PERFORMED WAS A LUMBAR SPINE STABILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496635 ↗