MalfunctionIYN

ACUSON ORIGIN

Received Apr 7, 2026 · Event occurred Mar 31, 2026

Report 3023245-2026-00032 · MDR key 24811874

Device

Generic name

System, Imaging, Pulsed Doppler, Ultrasonic

Manufacturer

Siemens Medical Solutions Usa, Inc.

Model number

11668590

Product problems

Application Program Freezes or Fails to Launch

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE#: (B)(4).

Description of Event or Problem

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.