MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10280959
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the reported issue was conducted by siemens experts by considering complaint description, service reports, system history, and system log files.Additional information was received that in the month when the increased radiation dose was recorded, on (b)(6) 2024, the artis zeego system displayed an error message "possible incorrect dose, cu prefilter, sc" to the user during an interventional procedure.The procedure was continued and finished on the same system.Following the procedure completion, the user informed siemens service organization about the error.The cu filter was exchanged as part of service activity, which resolved the problem.Detailed log file investigation confirmed the described above issue with the copper filter.The system always informs users of the pending problem by displaying the error message "possible incorrect dose, cu prefilter, sc" when using x-ray.The instructions for use advise limiting the use of the system to the minimum clinically necessary until the problem has been resolved.In this kind of scenario, the use of x-ray is not blocked as the benefit outweighs the risk of potentially increased dose applied to the patient.The total dose applied to the patient is continuously displayed on the monitor.Unintentional exposure to radiation is not conceivable, as it can be assumed that the user was aware of this problem during use of the system due to the error message displayed.This assumption is also confirmed by the fact that the field service was contacted for troubleshooting after the procedure.Regarding the claim that the higher dose reported on the employee's dose badge was caused by the system problem, cannot be estimated retrospectively without doubt.According to expert opinion, if the usual safety distances and radiation protection precautions are observed, it is very unlikely that the scattered radiation has exceeded more than a few mgy.It is the responsibility of the operator to take the necessary radiation protection precautions.The instructions for use contain adequate information about radiation protection.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis zeego unit.Siemens received information that the dose on an intervention radiologist's badge was significantly higher in (b)(6) 2024 than in other months.No information on the recorded dose was provided.No health consequences were reported for this event.

• Brand Name: ARTIS ZEEGO
• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 22740064
• Report Number: 3004977335-2025-00095
• Device Sequence Number: 7125693
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: (01)04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K181407
• 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
• Report Date (Section B): 08/07/2025

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: 10280959
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/07/2025
• 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