MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; ULTRASOUND DEVICE

Catalog Number	11575187
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I need to replace the z6ms transducer.
Event or Problem Description
Z6ms transducer image cannot be adjusted.When i looked at the image, i couldn't fix any angle and it returned to 0.Exam: cardiac there is no injury.Using a different system.

• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029 ; 6506257209
• MDR Report Key: 24376628
• Report Number: 3023245-2026-00016
• Device Sequence Number: 20068977
• Product Code: ITX
• UDI-Device Identifier: 04056869284583
• UDI-Public: 04056869284583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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
• Device Catalogue Number: 11575187
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown