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

Model Number	11343300
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of an issue with the mammomat revelation system.The customer communicated that when they arrived onsite in the morning, they found the protective glass shield on the console had shattered.No injury was communicated to siemens healthineers as a result of this event.It is assumed that in worst-case scenario, a serious injury might occur due to the flying pieces of glass.As of the date of this report, siemens healthineers has not been made aware of any injury that has occurred due to a breaking radiation glass shield, hence the probability for a serious injury to be the outcome is currently assessed with a frequency of inconceivable.However, this issue is reported with an abundance of caution because this event could potentially occur at any point in time with persons nearby.
Additional Manufacturer Narrative
H3, h6: initial actions (corrective and/or preventive): no general problem has been detected for the installed base which requires immediate action.Manufacturer's preliminary results and conclusion: the root cause for the glass shield breakage is currently unknown.The investigation is ongoing.Siemens healthineers will submit a supplemental report to the fda if additional reportable information is received and/or upon completion of the investigation.

• Brand Name: MAMMOMAT REVELATION
• 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: 24814792
• Report Number: 3004977335-2026-00045
• Device Sequence Number: 9594756
• Product Code: MUE
• UDI-Device Identifier: 04056869124575
• UDI-Public: (01)04056869124575
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 11343300
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/08/2026
• 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