O-ARMRecalls & reported problems across all models

We found 17 models of O-ARM by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 9,235 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Sep 30, 2026 — classified as 2 deaths, 62 injuries, 9,171 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (3,496 reports).

5 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

O-ARM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 19, 2026Open, Classified

   Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

   Z-2451-2026 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

2. Apr 26, 2024Open, Classified

   Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

   Z-2026-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Jul 25, 2023Open, Classified

   Ground cable installed incorrectly.

   Z-2449-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

4. Nov 15, 2019Terminated

   Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.

   Z-0767-2020 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

5. Aug 9, 2019Terminated

   Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

   Z-1995-2020 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported O-ARM problems

O-ARM models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• O-ARM® BI70002000

  Interventional fluoroscopic x-ray system
  2 recalls1 death3,667 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  2 recalls2,132 reports
• O-ARM® BI70000028120

  Image-intensified fluoroscopic x-ray system, mobile
  1,343 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  2 recalls1 death811 reports
• O-arm BI70002000

  Interventional fluoroscopic x-ray system
  2 recalls466 reports
• O-ARM® BI70002000

  Interventional fluoroscopic x-ray system
  1 recall287 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  259 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  2 recalls65 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  101 reports
• O-ARM® BI70002000

  Interventional fluoroscopic x-ray system
  1 recall20 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  23 reports
• O-ARM® BI70000028120

  Image-intensified fluoroscopic x-ray system, mobile
  19 reports
• O-arm BI70002000

  Interventional fluoroscopic x-ray system
  17 reports
• O-ARM® BI70002000

  Interventional fluoroscopic x-ray system
  16 reports
• O-ARM® BI70002000

  Image-intensified fluoroscopic x-ray system, mobile
  5 reports
• O-ARM® BI70000028120R

  Image-intensified fluoroscopic x-ray system, mobile
  3 reports
• O-ARM® BI70002000

  Interventional fluoroscopic x-ray system
  1 report

Recent O-ARM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem; Unintended Electrical Shock

  Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that the door winch cable grade was a C or D and required replacement. (Door Winch Cable Grade C/D). Confirmed reported complaint, "Door Winch Cable Grade C/D." Cable failed visual inspection. Cable was showing signs of wear and fraying. Worn cable. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943457 ↗
• MalfunctionSep 29, 2026Mechanical Problem; Failure to Advance

  Medtronic received information regarding an imaging system being used during a unknown procedure. It was reported that the systems gantry was unable to close or open. Site reported that the sterile drape may be stuck. There was unknown delay. There was unknown impact on patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929359 ↗
• MalfunctionSep 29, 2026Unintended Electrical Shock

  Medtronic received information regarding an imaging system being used outside of the procedure. It was reported that the ethernet cable had exposed wiring. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928484 ↗
• 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 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Medtronic received information regarding an imaging system being used during a cervical spine procedure. It was reported that during a cervical spine case they felt they were 5mm off (inferior) after the spin. They swapped the frame clamp and they were still off by 5mm (inferior) even after re-spinning with a new clamp (Alleged Inaccuracy). As they worked towards the frame they found that accuracy improved, but was never perfect. Additional information received "Resolution confirmed on call". This system had since been used with an AXiS and was seemed to be accurate".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916958 ↗
• MalfunctionSep 25, 2026Smoking; Arcing; Application Program Freezes or Fails to Launch

  Medtronic received information regarding an imaging system being used for a procedure. It was reported that the site had sparks and smoke emanating from the interconnect cable. patient was present but unknown procedure details. Additional information stating that "generator not booting correctly."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900404 ↗
• MalfunctionSep 25, 2026Display or Visual Feedback Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899325 ↗
• MalfunctionSep 23, 2026Failure to Advance; Noise, Audible

  Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that the gantry does not open when pressing the respective button on the pendant, and the gantry makes a loud sound when it does open. No patient was present at the time of event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865603 ↗
• MalfunctionSep 3, 2026Failure to Advance; Device Sensing Problem; Positioning Problem; Radiation Output Failure; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50579841 ↗
• MalfunctionAug 12, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220459 ↗
• MalfunctionMay 29, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE RAD TECHS HAD NOTICED A RING ARTIFACT ON PATIENT IMAGES DURING PHYSICS TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333108 ↗
• MalfunctionMay 26, 2026Noise, Audible; Radiation Output Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE 2D LONG FILM SPIN CANNOT BE TAKEN. AFTER REBOOT, SYSTEM WAS CONSTANTLY BEEPING WHEN ON. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278446 ↗
• MalfunctionMay 21, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A PORTION OF THE DETECTOR BLOCK WAS INTERMITTENTLY DROPPING OUT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241072 ↗
• MalfunctionMay 21, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD ARTIFACTS SHOWING UP IN BOTH THE 2D AND 3D IMAGES FOR SCANS. THE IMAGE LOOKS LIKE A BLACK VERTICAL STRIPE ACROSS THE LEFT SIDE OF THE IMAGE. THERE WAS UNKNOWN IMPACT ON PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240556 ↗
• MalfunctionMay 20, 2026Failure 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 REGARDING UNABLE TO MOVE GANTRY THAT THE SYSTEM WAS NOT RESPONDING TO COMMANDS TO MOVE OR OPEN. SYSTEM WAS DOWN. NO PATIENT WAS PRESENT AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228349 ↗

Other Medtronic Navigation, Inc. products

• StealthStation S8 Platform14 models · 8,402 reports
• Stealthstation S711 models · 5,756 reports
• StealthStation S86 models · 2,235 reports
• Fusion ENT Image Guidance System5 models · 2,033 reports
• Visualase25 models · 625 reports · 3 recalls
• NavLock9 models · 134 reports · 1 recall
• AxiEM12 models · 62 reports · 2 recalls
• StealthStation Cranial13 models · 2 reports · 3 recalls