ACUSON Origin Diagnostic Ultrasound System 11668590Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056869996295), received between Jan 23, 2025 and Sep 25, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Sharp Edges

  The Control Panel levers on the Origin system are prematurely fractured/cracked and a piece broke off. On the bottom of the handle there is a plastic piece that hangs down because it's broken off from the screw. It's very sharp and cut a sonographer on the night shift. A band-aid was applied but no medical intervention was required.

  Patient problems: Laceration(s)

  MAUDE report 50892813 ↗
• InjurySep 16, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791832 ↗
• MalfunctionApr 7, 2026Application Program Freezes or Fails to Launch

  DURING A TEE EXAM, THE SYSTEM STARTED DISPLAYING US_ICL_100, IMAGINGBE.EXE APPLICATION ERRORS, AND US_IFE_200 ERRORS. AFTER EACH REBOOT THE SYSTEM JUST DISPLAYED THE SAME ERRORS AFTERWARDS. THE SYSTEM HAD TO BE CHANGED OUT TO AN SC2000.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811874 ↗
• MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 8 AM CENTRAL TIME A FULL ECHO WAS PERFORMED AND A REPORT WAS SAVED, WITHOUT ENDING THE EXAM THE SONOGRAPHER THEN WENT INTO STRESS ECHO PROTOCOL (TREADMILL CONTRAST) AND PERFORMED NORMAL REST AND POST IMAGES. MEASUREMENTS WERE MADE ON THE POST STRESS IMAGES FOR EJECTION FRACTION. THE SONOGRAPHER STORED A SECONDARY REPORT THAT INCLUDED THE STRESS POST MEASUREMENTS. THE STUDY WAS ENDED AND SCENT TO PICOM (PACS). ON (B)(6) AM, ONE OF THE PHYSICIANS CALLED SAYING THERE ARE NO STRESS ECHO IMAGES SEEN ONLY THE ORIGINAL FULL ECHO. WHEN I ARRIVED, IT WAS PAST 24 HOURS AND YOU CAN NO LONGER APPEND IMAGES. THE FULL ORIGINAL EXAM WAS SEEN, AND THE POST IMAGES WITH CONTRAST THAT WERE MEASURED FOR EJECTION FRACTION AS WELL AS THE POST STRESS REPORT. HOWEVER, THERE WERE NO STRESS ECHO IMAGES ON THE STUDY. THE IMAGES JUMPED FROM NUMBER 91 TO NUMBER 183 ON THE THUMBNAILS, WITH NOTHING IN BETWEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801244 ↗
• MalfunctionMar 12, 2026Loss of Data

  CUSTOMER REPORTED TEE EXAM WAS LOST, ONLY SINGLE IMAGE OF PATIENT REGISTRATION IN PATIENT FOLDER. CUSTOMER STATED THAT THE UNIT DID BEEP AND THUMBNAILS WERE GENERATED ALONG WITH MEASUREMENTS SHOWING ON SCREEN, HOWEVER WHEN EXAM ENDED, NOTHING WAS AVAILABLE TO REVIEW OTHER THAN REGISTRATION PAGE IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576897 ↗
• MalfunctionJan 23, 2025Computer Software Problem; Computer Software Problem

  THIS IS A DUPLICATE MDR SUBMISSION TO MFR# 3023245-2024-00064. THE REPORT IS BEING RESUBMITTED DUE TO AN ISSUE WITH OUR INTERNAL COMPLAINT HANDLING TOOL, WHICH PREVENTED THE ORIGINAL REPORT FROM BEING PROPERLY PROCESSED. WE ARE SUBMITTING THIS TO ENSURE THE COMPLAINT IS APPROPRIATELY CLOSED AND ALL NECESSARY DOCUMENTATION IS ACCURATELY REFLECTED IN OUR SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225598 ↗