MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MOBILETT MIRA MAX; SYSTEM, X-RAY, MOBILE

Model Number	10594738
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
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 investigation is ongoing.Siemens healthineers will submit a supplemental report to the fda upon completion of the investigation.
Event or Problem Description
Siemens healthineers was notified of an issue with the mobilett mira max system.It was communicated that the emergency stop button was broken.Additional information provided by the service technician stated that the rear connection was broken from overturning the e-stop button and breaking the plastic threading on the button.This issue could result in the emergency stop not being activated when pressed.Although there was no injury associated with the complaint issue, in a worst-case scenario, not being able to activate the emergency stop could result in serious injury.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: SYSTEM, X-RAY, MOBILE
• 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: 25093360
• Report Number: 3004977335-2026-00077
• Device Sequence Number: 12013185
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: (01)04056869009131
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 10594738
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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