inforMED
MalfunctionIYN

ACUSON SC2000 ULTRASOUND SYSTEM

Received May 19, 2026 · Event occurred Apr 30, 2026

Report 3023245-2026-00035 · MDR key 25218108

Device

Generic name

Ultrasound Device

Model number

10433816

Product problems

  • Image Display Error/Artifact

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

THE USER REPORTED A SYSTEM DELAY IN RESPONSE WITH THE ACUSON SC2000. THE SYSTEM WAS NOT TRANSFERRING A SMOOTH IMAGE TO THE CUSTOMER'S CARTOPC. THIS OCCURRED DURING A CATHETER EXAM. A DIFFERENT ULTRASOUND SYSTEM WAS USED TO COMPLETE THE EXAM. THERE WAS NO INJURY.