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

Model Number	11372950
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of an issue involving the mammomat b.Brilliant system.According to the provided information, the swivel arm of the system collided with a biopsy chair which was positioned within in the collision range of the tube arm.On (b)(6) information was received that a patient was sitting in the chair and was compressed during the collision.No patient injury was communicated.In a worst-case scenario, a critical injury could result if the issue were to recur.
Additional Manufacturer Narrative
H3, h6: manufacturer's preliminary results and conclusion: according to the available information, a positioning error is assumed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.It was stated that during a tomo examination the tube collided with the biopsy chair.The investigation at customer site performed by a service technician confirmed that the lower side of the tube cover hit the biopsy chair without causing damage on the cover.Additionally, the image quality was criticized.An analysis of the available images identified that the arm rest of the biopsy chair was in the beam field during examination.Based on all investigation results no system malfunction could be determined.In general, the operating personnel must ensure to exclude all dangers for the patient or other persons before system movements are initiated and no patient body parts are in the collision zones.This is also described within the operator manual (xpw7-400g.620.01.05.From page 38, chapter 2.3 mechanical safety).The complaint is closed.No further action is needed.

• Brand Name: MAMMOMAT B.BRILLIANT
• 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: 24413154
• Report Number: 3004977335-2026-00028
• Device Sequence Number: 5878038
• Product Code: MUE
• UDI-Device Identifier: 04056869987187
• UDI-Public: (01)04056869987187
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 11372950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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