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

Model Number	10849000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was performed by our experts.Detailed log-file investigation showed that during the shutdown procedure, the ivs and image acquisition system (ias) crashed abruptly without any further logging activity hinting toward possible hw failure.The reported issue was reproduced, and it was identified that the abrupt system shutdown issue observed after upgrading from the sw version ve10 to ve30 is caused by a firmware defect in the control interface box (cib), specifically in the lab power interface (lpi) firmware version 01.The issue is caused by the delay counter variable not being reinitialized after the first shutdown.As a result, subsequent shutdowns could bypass the intended delay, leading to an abrupt power-off approximately 4 seconds after the shutdown command, resulting in the reported issue.Additionally, it is noted that the issue occurs during a second shutdown only after a complete power cycle of the control interface box (cib) due to a power cut/failure.As a result, the robot cannot be moved immediately after booting due to no communication between the robot and the ivs.In the reported case, normal system functionality was restored by a service intervention.This issue is determined to be sporadic but systematic for the mentioned configuration with the sequence of events mentioned above.Since only systems that have cibs with firmware version 01 are affected, the ve10 to ve30 upgrade has been adapted, thus preventing further distribution of the problem to other systems.An update instruction ax032/25/s will be released by siemens for the affected systems to eliminate the issue.
Event or Problem Description
Was shut down as normal sequence via the image visualization system (ivs) but when turning on the system the next time system movements were blocked.No health consequences were reported to this event.
Additional Manufacturer Narrative
Correction for section b5 due to a missing sentence.Siemens became aware of a malfunction that occurred while operating the artis pheno system.The machine was shut down as normal sequence via the image visualization system (ivs) but when turning on the system the next time system movements were blocked.No health consequences were reported to this event.

• Brand Name: ARTIS PHENO
• 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: 22586812
• Report Number: 3004977335-2025-00085
• Device Sequence Number: 4502098
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K241572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 10849000
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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