MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM X.CEED; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that an incident occurred while operating the somatom x.Ceed ct-system.During a stroke examination of an 82-year-old male patient, the patient was restless and difficult to position.The perfusion scan including contrast medium was performed three times.Because the customer could not evaluate the data manually, neither after three scans, an additional mri examination was performed to rule out a stroke.The three scans took about 28 minutes, which is rated as the delay in diagnosis for the patient.We are unaware of any impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be related to use.Diagnostically usable ct image data was correctly acquired in all three scans and could have been evaluated.The ct system functioned as specified.No further corrective or preventive actions for the device are required.

• Brand Name: SOMATOM X.CEED
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 24895411
• Report Number: 3004977335-2026-00063
• Device Sequence Number: 13020876
• Product Code: JAK
• UDI-Device Identifier: 04056869231051
• UDI-Public: (01)04056869231051
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K233650
• 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
• Report Date (Section B): 04/16/2026

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: 11330002
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/16/2026
• 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: 82 YR
• Patient Sex: Male