STEPHANIX D2RS_9090_B1_NV2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03664049001052), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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.

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.

• MalfunctionJul 15, 2025Unintended Movement; Unintended Movement

  DURING A MOVEMENT ORDERED FROM THE CONSOLE BY A RADIOLOGY OPERATOR, THE TABLE DID NOT STOP. NO PATIENT, NO INJURY. THE USER DID NOT USE THE EMERGENCY STOP BUTTONS. AFTER ANALYSIS OF THE LOGS BY OUR SUPPORT TEAM, WE FOUND THAT WHEN THE TILTING CONTROL WAS RELEASED, A BUG OCCURRED IN THE INVERTERS AND MOVEMENT CONTINUED WITHOUT REACHING THE LIMIT SWITCH. WE HAVE IMPLEMENTED A HARDWARE SAFETY WHICH MONITORS IF AN ABNORMAL SITUATION LIKE THIS OCCURS AND CUTS THE POWER SO THAT THE MOVEMENT STOPS IMMEDIATELY. DURING THIS ISSUE, THE CONTACTOR FAILED TO OPEN PROPERLY AND THE EQUIPMENT REMAINED POWERED. OUR TECHNICAL TEAM ADJUSTED THE LIMIT SWITCH AND CHANGED THE CONTACTOR (MANUFACTURED BY SCHNEIDER ELECTRIC), THE COMPONENT THAT CUTS OFF THE POWER WHEN THE PROBLEM OCCURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506256 ↗