Advanced Universal U-Arm Stand 4000 XR3500BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817100020056), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2018Mechanical Problem; Unintended System Motion; Unintended Movement; Mechanical Problem; Unintended System Motion; Unintended Movement

  IT WAS REPORTED BY THE ENGINEER THAT OUR CUSTOMER CONTACTED THEM STATING THAT DURING A HIP LATERAL EXPOSURE THE STAND STARTED MOVING AND LIFTING UP THE TABLE WITH THE PATIENT ON IT. THERE WERE THREE TECHNICIANS OBSERVING THE PROCEDURE. TECHNICIAN #1 RAN INTO THE ROOM AND WAS ABLE TO MOVE THE TABLE WITH THE PATIENT ON IT OUT OF THE WAY. TECHNICIAN #2 PRESSED BUTTONS ON THE TABLET ENCLOSURE AND THE STAND STOPPED MOVING. A TECHNICIAN STATED THAT DURING THE ALLEGED MALFUNCTION, THE REMOTE WAS LAYING ON THE COUNTER AND THAT THE ONLY PERSON IN THE ROOM WAS THE PATIENT. TECHNICIAN #3 WAS THERE AND OBSERVED IT ALL OCCUR. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSIST CMS IMAGING ENGINEER TROUBLESHOOT BY PHONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7976027 ↗