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STEPHANIX D2RSRecalls & reported problems

Stephanix · D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections. Not for mammography. · Class 2

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 03664049000017), received between Jun 7, 2018 and Jun 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended System Motion” (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

Device problems

  • Unintended System Motion1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 7, 2018Unintended System Motion; Unintended System Motion

    THE TABLE WAS IN VERTICAL POSITION, THE OPERATOR WANTED TO MOVE THE TABLE WITH JOYSTICK, BUT WHEN HE RELEASED THE COMMAND, THE TABLE KEPT MOVING UNTIL HE USED THE EMERGENCY STOP. THUS WE HAVE UNCOMMANDED TABLE MOVEMENT.

    Patient problems: No Information

    MAUDE report 7577669 ↗

Other System, X-Ray, Fluoroscopic, Image-Intensified devices

All System, X-Ray, Fluoroscopic, Image-Intensified devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.