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

Model Number	10762444
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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): system is taken out of use until service checkup and correction.Manufacturer's preliminary results and conclusion: according to the available information, an installation issue is assumed.The investigation is ongoing.A supplemental report will be submitted to the fda if additional reportable information is obtained by siemens healthineers or upon completion of the investigation.
Event or Problem Description
Siemens healthineers was notified of an installation issue involving the mammomat fusion system.According to the complaint report, this system was not correctly installed in a mobile unit.Although no injury was communicated, an incorrect installation of this system in a mobile unit could result in a serious injury.

• Brand Name: MAMMOMAT FUSION
• Common Device Name: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 24413145
• Report Number: 3004977335-2026-00027
• Device Sequence Number: 10569778
• Product Code: MUE
• UDI-Device Identifier: 04056869009070
• UDI-Public: (01)04056869009070
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: 10762444
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/23/2026
• 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