MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848600
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Code	Hair Loss (1877)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the event.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Siemens was informed about potential radiation overexposure on the artis one system.On (b)(6) 2025, a patient underwent a cerebral aneurysm embolization procedure.On (b)(6) 2025, the patient returned to hospital and reported to have experienced hair loss subsequent to the procedure.The customer requested to check the radiation dose delivered on the day of the involved procedure.The system is being tested by a siemens local service team.Siemens requested additional information about this event.
Additional Manufacturer Narrative
The investigation of the reported case has been completed.The log file analysis was performed for further investigation.The log dated oct 03, 2025, showed that patient registration was done at 10:53:03, and patient was closed at 13:41:38.X-ray lasted from 11:05:44 to 13:32:30 with full functionality.No errors and no malfunctions of the system were observed.System worked as specified.The user confirmed the system concerned was working fine during the procedure, and the dose was displayed correctly on the monitor and was fully visible to the user.The procedure lasted for two hours and 48 minutes, for which the accumulated dose was 2195.4mgy with 191 fluoroscopies for 67.1 minutes (about 1724.6mgy) and 37 acquisitions for 5.3 minutes (about 470.7mgy).The applied dose was the intended dose essential for the procedure.Permanent epilation is a known side effect of x-ray application for radiation emitting products.The related risk can be minimized by means of keeping the x-ray exposure to the necessary minimum.The suggestions for optimization of exposure parameters have been provided to the customer, their intentions are to minimize the x-ray dose or reduce the x-ray radiation effect for long-time procedures.The system worked according to its specifications.The system did not cause or contribute to the patient hair loss.

• Brand Name: ARTIS ONE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center gaoxin c av; shenzhen 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 23605505
• Report Number: 3004754211-2025-00004
• Device Sequence Number: 9112209
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: (01)04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848600
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown