O-ARM® BI70002000 (UDI 00643169983021)Recalls & reported problems
Medtronic Navigation, Inc. · O-ARM RFB BI70002000 O2 UE 120V B EN UEN · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169983021), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Application Program Freezes or Fails to Launch1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2025Poor Quality Image; Application Program Freezes or Fails to Launch; Poor Quality Image; 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 X-RAY GENERATOR SECTION MALFUNCTIONING. THE SYSTEM WAS ABLE TO TAKE 2D AND 3D SHOTS INTERMITTENTLY. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AFTER RESTARTING THE SYSTEM. IT WAS FOUND THAT THE POWER SUPPLY VOLTAGE WAS FLUCTUATING WHICH WAS CAUSING THE ISSUE WITH INTERMITTENCE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447648 ↗
Other Interventional fluoroscopic x-ray system devices
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- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System32 recalls2 deaths2,308 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system2 recalls1 death3,667 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System28 recalls1 death2,176 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths2,015 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System20 recalls2 deaths1,837 reports
- Azurion Azurion 7 M12Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System24 recalls2 deaths1,087 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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