MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON Z6MS ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number	10436113
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when connecting the z6ms probe, the device displays the error usacquisitionhw_31 and the system requests the removal of the probe.The issue is thermal in nature and occurs every time the probe is connected.When connecting v5m tee probes, the error does not occur.This occurred during an exam and the physician interrupted the exam by shutting down the equipment and removing the transducer from the patient.The exam was completed with a regular (non-4d) tee transducer.
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).

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS HEALTHINEERS; 22010 south east 51st street; issaquah WA 98029
• Manufacturer (Section G): SIEMENS HEALTHINEERS; 22010 south east 51st street; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 south east 51st street; issaquah, WA 98029
• MDR Report Key: 23417224
• Report Number: 3023245-2025-00070
• Device Sequence Number: 9084708
• Product Code: ITX
• UDI-Device Identifier: 04056869002804
• UDI-Public: (01)04056869002804
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10436113
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown