MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG CIOS ALPHA VA3X; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	11105200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.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 cios alpha va3x system.During an emergency patient procedure, the image intensifier malfunctioned, which led to a long term delay.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation of the reported issue was completed by our experts with the following result.The detailed logfile investigation showed that the message "rx terminated too early due to an internal error.Re-trigger if necessary." was displayed to the user several times due to a communication error between the trolley and the c-arm.The user then restarted the system.However, due to the pending communication error, the restart took 2-3 times longer (about 10 minutes) than usual.After the system was finally restarted, there were no more communication errors.The onsite service intervention showed loose contact in the x10 plug, which is part of the cable that connects the trolley and the c-arm.The cable was replaced as part of a service activity.The detailed investigation of the replaced cable confirms a defective x10 plug.The cable also shows signs of heavy wear, most likely due to improper handling.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: CIOS ALPHA VA3X
• 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: 23943480
• Report Number: 3004977335-2026-00002
• Device Sequence Number: 7869013
• Product Code: OWB
• UDI-Device Identifier: 04056869153490
• UDI-Public: (01)04056869153490
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K251520
• 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): 02/10/2026

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
• Device Model Number: 11105200
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/10/2026
• 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 Age: 68 YR
• Patient Sex: Unknown