MAUDE Adverse Event Report: SIEMENS HEALTHCARE AG MAMMOMAT REVELATION; FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number	11343300
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the event was reported by a siemens healthineers employee, and a facility contact name and phone number were not provided for reporting purposes.H3, h6: initial actions (corrective and/or preventive): currently the issue is under investigation.It is recommended to check all parts that have not been stored in boards or were secured in longitudinal, sagittal, transversal direction during transport.It shall be confirmed that connectors or other cables are securely attached to the respective component.Manufacturer's preliminary results and conclusion: this operator table was not approved for a mobile vehicle.Although this incident occurred in new zealand, the circumstance seems similar to the us recall res # 97920.Further information was requested and investigation is on-going.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An operator table intended for stationary use was installed in a mobile vehicle.If the user does not notice a potentially loose monitor after transportation, in a worst-case scenario, this issue could lead to a minor to serious injury.No loose monitor was communicated in this case.No injury was communicated.

• Brand Name: MAMMOMAT REVELATION
• Common Device Name: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 24507681
• Report Number: 3004977335-2026-00031
• Device Sequence Number: 13251929
• Product Code: MUE
• UDI-Device Identifier: 04056869124575
• UDI-Public: (01)04056869124575
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K193166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: 11343300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/04/2026
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown