Multix Fusion Max 11020660Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869050713), received between Feb 24, 2021 and Mar 13, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  SIEMENS HEALTHINEERS WAS INFORMED OF A PRODUCT MALFUNCTION AND ADVERSE EVENT ASSOCIATED WITH THE MULTIX FUSION MAX SYSTEM. THE TECHNICIAN WAS MOVING THE X-RAY TUBE FROM THE WALL BUCKY TO THE TABLE TO PERFORM A TABLETOP X-RAY WHEN THE TUBE STAND UNEXPECTEDLY ENGAGED INTO DETENT POSITION. THE TECHNICIAN WAS AT THE HAND CONTROL WHEN THE X-RAY TUBE MOVEMENT LOCKED. THE TECHNICIAN¿S ARM WRENCHED UP AND BACK, AND THE MOMENTUM CARRIED HIM FORWARD. THE TECHNICIAN'S SHOULDER WAS INJURED DURING THIS EVENT, AND HE WENT TO THE EMERGENCY ROOM WHERE HE RECEIVED AN ULTRASOUND EXAMINATION. IT WAS DETERMINED THAT THE TECHNICIAN SUFFERED A FULL THICKNESS TEAR OF THE SUPRASPINATUS TENDON. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024, STATING THE TECHNICIAN IS STILL ABLE TO PERFORM HIS WORK DUTIES AND HAS NOT NEEDED TIME OFF WORK DUE TO HIS INJURY. THE TECHNICIAN STARTED PHYSIOTHERAPY AT THE BEGINNING OF (B)(6) 2024 (EXACT DATE UNKNOWN) AND IS UNDER THE CARE OF A SPORTS MEDICINE SPECIALIST. THERE WAS NO PATIENT INVOLVEMENT IN THIS INCIDENT.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18893716 ↗
• InjuryFeb 24, 2021Use of Device Problem; Use of Device Problem

  WHILE PERFORMING SERVICE ON THE MULTIX FUSION MAX UNIT, SIEMENS LOCAL SERVICE ENGINEER NOTICED THAT ONE OF THE FOUR STEEL CORNERS OF THE DETECTOR POPPED OFF FROM THE DETECTOR. THE STEEL CORNER WAS JAMMED INSIDE THE DETECTOR'S BUCKY TRAY. THE USER WAS COVERING THE PEELING DETECTOR COVER WITH TAPE. SIEMENS WAS INFORMED OF A MINOR INJURY CAUSED BY THE PEELING DETECTOR COVER. THE OPERATOR SLIGHTLY CUT HAND ON THE PEELING EDGE; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11372664 ↗