MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG LUMINOS LOTUS MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	11574100
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: initial actions (corrective and/or preventive): currently, no general problem has been detected for the installed base which requires an immediate action.Manufacturer's preliminary results and conclusion: the root cause for the issue has not yet been determined.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information is obtained after the completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of an event associated with the luminos lotus max system.The customer communicated when tilting the system from a vertical to horizontal position, the x-ray tube contacted the ceiling.The ceiling plate lifted without any damage or deformation of the x-ray tube.The system was being prepared for an examination and there was no patient on the table at the time of the event.There were no injuries resulting from the event.In a worst-case scenario, if the event issue were to recur, serious injury could result from falling parts.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.It was stated that when tilting the system from vertical to horizontal position the x-ray tube contacted with the ceiling.It was further communicated that no error messages were displayed.The investigation at customer site performed by the service engineer identified that the ceiling height was measured incorrectly during installation.The actual room height is five centimeters lower than originally measured.Therefore, the incorrect value was stored in the room configuration.In general, correctly measured distances are the foundation for a correct working collision calculation.An incorrectly configured ceiling height is directly related to this collision calculation.The correct measurement and configuration are described in the start-up instruction in chapter 4.3.This document was checked and found to be sufficient.Based on the available investigation results it was determined that the incorrect room height measurement resulted in an incorrect room configuration.The collision model was calculated with the room height higher than it actually is.Thus, the system was allowed to drive closer to the ceiling than intended and the tube could touch the ceiling.No system malfunction could be identified.The system is now fully functional with the correct room configuration parameters.The complaint has been closed this statement.

• Brand Name: LUMINOS LOTUS MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 22800256
• Report Number: 3004977335-2025-00097
• Device Sequence Number: 15650774
• Product Code: OWB
• UDI-Device Identifier: 04056869269931
• UDI-Public: (01)04056869269931
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173639
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 11574100
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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