O-ARM® BI70000028120RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169589292), received between Apr 22, 2020 and Jan 14, 2021 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2021Application 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 WILL FREQUENTLY ENTER STAND ALONE MODE, BUT WHEN THE SITE ADJUSTS THE UMBILICAL CORD, THE SYSTEM WILL EXIT STANDALONE MODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11169881 ↗
• MalfunctionAug 13, 2020Failure to Run on Battery; Failure to Run on Battery

  IT WAS INITIALLY REPORTED THAT THIS OCCURRED OUTSIDE OF A PROCEDURE, HOWEVER, THE SYSTEM CHECKOUT REFERENCES A "CRITICAL BATTERY EVENT THAT OCCURRED DURING THE CASE." IT OCCURRED BEFORE THE PROCEDURE. THERE WAS ENOUGH BATTERY LIFE TO PERFORM THE SPIN THAT WAS NEEDED FOR THE CASE

  Patient problems: No Patient Involvement

  MAUDE report 10402489 ↗
• MalfunctionApr 22, 2020Application 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 IMAGING SYSTEM WAS AUTOMATICALLY GOING INTO E-STOP AS IF THE BUTTON WAS BEING PRESSED. HOWEVER THE BUTTON WAS NOT BEING PRESSED. THIS OCCURRED MULTIPLE TIMES WHILE DRIVING THE SYSTEM AND DURING STAFF TRAINING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9985706 ↗