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

Model Number	10848281
Medical Device Problem Codes	Defective Component (2292); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q ceiling unit.During an emergency patient procedure, no x-ray was available.The patient had to be moved to complete the procedure on an alternate unit.It is assumed that an x-ray tube was defective.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
The investigation of the reported event was completed with the following result.When the user attempted to release x-ray following a focus failure, the system detected the fault and aborted the exposure.After three unsuccessful attempts, the system automatically switched to the next available larger focus.The switchover to the large focus worked as intended.Based on the available information and log file analysis, both the micro and small focal spots had been defective for an extended period, and the customer was aware of these conditions.The micro focus had been non-functional since 2022, and the small focus since 2023.In february 2025, siemens local service engineer conducted an onsite troubleshooting and recommended replacement of the x-ray tube.However, the customer declined the quotation and continued operating the system using only the remaining large focus.Due to continuous operation under high load, the large focus subsequently became overloaded and failed.As a result, no functional focal spot remained, leading to a complete loss of x-ray.This time the x-ray tube was replaced by a siemens engineer.Following the exchange of the x-ray tube the system worked as intended.Investigation of the returned component confirmed that both the small and large focal spots exhibited signs of overload.Additionally, the cathode welding point of the micro focus was found to be defective, and the focal track showed evidence of overload.The root cause of the non-conformity was determined to be a defective and progressively degraded x-ray tube, further impacted by continued operation despite known focal spot failures.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.

• Brand Name: ARTIS Q CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittgfeld 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: 24220439
• Report Number: 3004977335-2026-00014
• Device Sequence Number: 8579316
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: (01)04056869009988
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/05/2026

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: 10848281
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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