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

Model Number	10848280
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q floor device.The user reported that the system neither generated a dose report nor displayed it on the monitor.Additional information was provided that the issue occurred during a patient procedure, which was continued on the same system.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Detailed investigation of the available log files showed no dose regulation issue.The dose levels were in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.However, the dose was not displayed on the monitor as the dose area profile (dap) chamber, which is used for the dose value display, was defective.The chamber was replaced as part of a service activity, which resolved the issue.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.The dose display issue does not have affect system functionalities, e.G., x-ray, movement, or the dose regulation.The incident described in the adverse event is therefore not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.

• Brand Name: ARTIS Q FLOOR
• 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; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 24282724
• Report Number: 3004977335-2026-00020
• Device Sequence Number: 15533465
• Product Code: OWB
• UDI-Device Identifier: 04056869009971
• UDI-Public: (01)04056869009971
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/20/2026

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: 10848280
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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