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

Model Number	10762472
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of an issue with the luminos agile max system related to siemens recall xp017/24/s ui xp018/24/s, res #94948.It was discovered that at the fixation of the monitor ceiling suspension the securing segment was not installed correctly.The monitor support arm remained attached to the ceiling and no injury occurred due to this issue.It is assumed that in a worst-case scenario, if the support arm had been used further without noticing the issue, a serious injury could be sustained from falling equipment.
Additional Manufacturer Narrative
Manufacturers preliminary analysis: the root cause for the issue has not yet been determined.The investigation is ongoing.The root cause will be communicated via res# 94948.Corrective/preventative actions for this system were completed via ui xp018/24/s.Siemens will not submit a supplemental report because the issue, and the complaint system status, will be addressed in res# 94948 reports to the fda.
Additional Manufacturer Narrative
H11: corrected data: d3: the manufacturer's name was corrected to siemens healthineers ag.

• Brand Name: LUMINOS AGILE 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: 21503082
• Report Number: 3004977335-2025-00031
• Device Sequence Number: 19933445
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 94948
• Patient Sequence Number: 1
• Patient Sex: Unknown