O-ARM® BI70002000 (UDI 00763000584115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000584115), received between Aug 10, 2022 and Jun 30, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 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 IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE COULD NOT OPEN THE GANTRY WHILE IT WAS AROUND A PATIENT. THE SITE TRIED REBOOTING AND USING THE YELLOW BUTTON TO OPEN THE GANTRY, BUT THE SYSTEM DID NOT RESPOND. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE AFTER A SPIN, AND THE SCREEN WENT BLACK. IT IS UNKNOWN IF THERE WAS A DELAY TO THE PROCEDURE, AND IF THERE WAS AN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO IMPACT TO THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364467 ↗
• MalfunctionJun 30, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO OPEN OR CLOSE THE GANTRY. SITE TRIED REBOOTING AND USING THE YELLOW BUTTON FOR OPENING THE GANTRY WITH NO CHANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356429 ↗
• MalfunctionJun 27, 2025Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GANTRY WOULD NOT OPEN AFTER A SPIN. REBOOTING RESOLVED THE ISSUE. THERE WAS NO DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344316 ↗
• MalfunctionMar 3, 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 THE PENDANT SCREEN OF THE SYSTEM WAS BLACK (PENDANT ISSUES), THE SYSTEM WAS UNABLE TO DRIVE, AND THERE WAS NO MOTION. IT WAS CONFIRMED THAT NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502779 ↗
• MalfunctionFeb 5, 2025Radiation Output Failure; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT THE GANTRY ROTOR WAS STOPPED ABRUPTLY DURING SPINS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314725 ↗
• MalfunctionDec 2, 2024Application Program Problem; Wireless Communication Problem; Radiation Output Failure; Application Program Problem; Wireless Communication Problem; Radiation Output Failure

  ADDITIONAL INFORMATION STATING THAT THERE WAS NO IMPACT ON PATIENT OUTCOME AND UNKNOWN PATIENT WIGHT, AGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818531 ↗
• MalfunctionOct 28, 2024Radiation 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 SYSTEM WAS NOT SHOOTING X-RAY. THE SYSTEM STAYED IN STAND-ALONE MODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543307 ↗
• MalfunctionJul 17, 2024Failure to Advance; Noise, Audible; Failure to Advance; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE GANTRY WAS UNABLE TO FULLY CLOSE AND THE SITE BELIEVED THEY HEARD THE SYSTEM HITTING SOMETHING INTERNALLY. NO OTHER INFORMATION AVAILABLE AT TIME OF CALL. PATIENT PRESENT. UNKNOWN DELAY AND PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761161 ↗
• MalfunctionMay 14, 2024Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS BOOTING UP THE SYSTEM, IT POWERED ON INTO THE STANDALONE MODE WHILE CONNECTED TO THE MOBILE VIEWING STATION (MVS). IT WAS ALSO NOTED THAT THE M CALIBRATION BAR WAS PRESENT ON THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311768 ↗
• MalfunctionMay 1, 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 MOBILE VIEW STATION (MVS) WAS DISPLAYING AN ERROR MESSAGE STATING THAT AN ERROR OCCURRED THAT HAS COMPROMISED THE INTEGRITY OF THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220428 ↗
• MalfunctionNov 16, 2023Failure 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 THE SYSTEM WAS HAVING DIFFICULTY OPENING. TO BE MORE PRECISE, THE BUTTON ON THE PENDANT REQUIRED BEING HELD DOWN EXTREMELY HARD, TECH STATED THAT BOTH HANDS NEEDED TO BE USED AND HAD TO PRESS THE BUTTON SEVERAL TIMES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148153 ↗
• MalfunctionMar 22, 2023Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DOOR TO THIS SYSTEM WAS NOT ABLE TO OPEN. WHEN THE DOOR OPEN BUTTON WAS PRESSED THERE WAS A CLICKING NOISE BUT NO MOVEMENT. ATTEMPTED TO MANUALLY OPEN THE DOOR WITHOUT SUCCESS. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589915 ↗
• MalfunctionFeb 28, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE BOOST BUTTON ON THE HAND SWITCH WAS NOT FUNCTIONING. THE OTHER BUTTONS WORKED, BUT NOT THE BOOST. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452059 ↗
• MalfunctionJan 10, 2023Use of Device Problem; Application Program Freezes or Fails to Launch; Use of Device 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 GENERATOR WAS INTERMITTENTLY RESPONSIVE.  WHEN THE REPRESENTATIVE ON SITE WENT TO EXPOSE, THE GREEN LIGHT GOES OFF AND CLICKS LIKE IT WOULD EXPOSE BUT IT DOES NOT. IT WAS NOTED THAT IF THE REP TRIES TO EXPOSE MULTIPLE TIMES IN A ROW THEN EVENTUALLY IT MIGHT WORK ONCE. THE RESULTS WERE THE SAME FOR THE HANDSWITCH AND FOOTSWITCH. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130670 ↗
• MalfunctionSep 7, 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 SYSTEM WAS USED FOR A SCOUT SHOT, BUT THEN THE SYSTEM WENT UNRESPONSIVE AND COULD NOT BE USED. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371396 ↗
• MalfunctionAug 10, 2022Failure to Run on Battery; Physical Resistance/Sticking; Unexpected Shutdown; Failure to Run on Battery; Physical Resistance/Sticking; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT HOLDING A CHARGE. IT COULD TURN ON IF CONNECTED TO MVS THAT IS CONNECTED TO WALL POWER, BUT AS SOON AS THE MVS WAS UNPLUGGED FROM THE WALL, THE IAS SHUT OFF. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202239 ↗