ACUSON S1000 Diagnostic Ultrasound System 10441701Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869002750), received between Feb 3, 2025 and Sep 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904354 ↗
• MalfunctionMay 20, 2026Device Fell

  IT WAS REPORTED THAT THE CONTROL PANEL/USER INTERFACE HEIGHT DROPS REALLY FAST AND DOES NOT STAY LOCKED IN PLACE. THE UI CAME DOWN ONTO THE USER'S LEG WHILE SEATED IN THE STOOL/CHAIR. THE INJURY REPORTED WAS MINOR PER THE USER.

  Patient problems: Pain

  MAUDE report 25236838 ↗
• MalfunctionFeb 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: 1. THE CUSTOMER FOUND THAT THE SYSTEM COULD GET HANG UP FREQUENTLY, CAUSING ALL BUTTONS TO LOSE RESPONSE. CUSTOMER ATTEMPTED TO RESTART THE DEVICE WITHOUT ANY IMPROVEMENT. THE CUSTOMER IMMEDIATELY ARRANGED FOR THE PATIENT TO COMPLETE THE EXAMINATION IN ANOTHER ROOM. NO OTHER PATIENTS WERE AFFECTED. AFTER THE INCIDENT, THE CUSTOMER DID NOT REPORT TO SIEMENS. THEY REPORTED THE INCIDENT TO REGULATORY AUTHORITY AS AE, SIEMENS WAS REQUIRED TO EVALUATE THE POTENTIAL RISK. 2. HOSPITAL'S AE REPORT DESCRIBED INCIDENT AS "ON (B)(6) 2024, DOCTORS PERFORMED AMNIOCENTESIS ON PATIENTS UNDER THE GUIDANCE OF THE ULTRASOUND DIAGNOSTIC SYSTEM. DURING THE PUNCTURE PROCESS, THE ULTRASOUND DIAGNOSTIC SYSTEM SUDDENLY WENT BLACK AND FAILED TO CONTINUE SUPERCONDUCTIVITY. EVEN AFTER RESTARTING, IT STILL COULD NOT BE TURNED ON NORMALLY, AND THE BLACK SCREEN REMAINED IN A CONTINUOUS STATE. IMMEDIATELY START ANOTHER BEDSIDE ULTRASOUND MACHINE TO CONTINUE PERFORMING AMNIOCENTESIS FOR THE PATIENT. IF THE PATIENT DOES NOT EXPERIENCE ANY SPECIAL DISCOMFORT AFTER THE SURGERY, REPORT TO THE DEPARTMENT DIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292497 ↗