inforMED
MalfunctionITX

Z6MS TRANSDUCER

Received Jun 1, 2026 · Event occurred May 25, 2026

Report 3023245-2026-00040 · MDR key 25350851

Device

Generic name

Transducer, Ultrasonic, Diagnostic

Model number

11575187

Product problems

  • Overheating of Device

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 AN ESOPHAGEAL ULTRASOUND AFTER INSERTION INTO THE PATIENT, A TEMPERATURE ERROR MESSAGE APPEARED AND THE SYSTEM FROZE. AFTER REINSERTING THE TRANSDUCER INTO THE SYSTEM, AN IMAGE APPEARED BRIEFLY. HOWEVER, THE ERROR MESSAGE APPEARED AGAIN SHORTLY AFTER. A NEW ULTRASOUND SYSTEM WAS USED TO COMPLETE THE EXAM. AFTER THE EXAM, THE SYSTEM WAS RESTARTED AND NO ERROR MESSAGES WERE DISPLAYED. THERE WAS NO PATIENT IMPACT REPORTED.