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

Model Number	10848282
Medical Device Problem Codes	Failure to Power Up (1476); Power Problem (3010); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a comprehensive investigation into the reported event.As the investigation is ongoing, the root cause has not yet been established.A supplemental report will be submitted as soon as additional relevant information becomes available, and a final report will be provided upon completion of the investigation.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q biplane system.During an emergency patient procedure, the system would not power up.The patient had to be moved to complete the procedure on an alternate unit.No injuries or adverse health effects have been reported in connection with this event.
Additional Manufacturer Narrative
The investigation was performed on expert discussions (considering complaint description, cs (customer service) reports, system history, system log files).During an emergency procedure on the artis biplane system, a power failure was observed in ¿plane a¿, resulting in a loss of x-ray functionality for that plane, while plane b remained operational.Considering the procedural circumstances, the patient was transferred to an alternate system, and the procedure was successfully completed without any reported adverse health consequences.During onsite troubleshooting, the customer service engineer (cse) identified an issue with transformer (t3) in the ¿plane a¿ generator cabinet.As a result, the required voltage was not supplied to the generator, leading to the observed failure.The cse replaced transformer (t3) in ¿plane a¿, after which the system functionality was restored.A detailed investigation could not be carried out, as the affected transformer was not returned and had been locally scrapped.Consequently, a retrospective determination of the exact root cause was not possible.However, the malfunction of transformer (t3) was identified as the cause of the non-conformity.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 BIPLANE
• 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: marion mints ; 40 liberty blvd.; malvern, PA 19355 ; 4843231632
• MDR Report Key: 24376679
• Report Number: 3004977335-2026-00025
• Device Sequence Number: 4862657
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: (01)04056869009995
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 10848282
• 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: 02/15/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/09/2026
• 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