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

Model Number	10848281
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q ceiling system.During an emergency procedure on the patient with acute myocardial infarction, the system movements were not possible.The user tried restarting the machine, but the system still could not be moved.The patient was moved and the procedure was successfully completed on an alternate unit.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 issue was completed by siemens experts.The user declined an onsite service visit by a siemens local service engineer.According to the information provided by the customer, a power supply unit within the real-time controller (rtc) required repair.The repair was performed by the user facility without siemens involvement.As a result, a more detailed and independently verifiable analysis of the issue described in the complaint could not be conducted.No log files or other necessary information were provided for further analysis.A possible general error that would require corrective measures of the installed base could not be determined.

• Brand Name: ARTIS Q CEILING
• 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; foechheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 24569062
• Report Number: 3004977335-2026-00032
• Device Sequence Number: 9434441
• 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): 03/23/2026

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: 03/01/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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