MAUDE Adverse Event Report: SAMSUNG HME AMERICA, INC. NL4100; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL4100
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The system experienced two lockups, requiring a reboot each time.Additionally, the scanner is displaying a message indicating that the x-ray tube needs to be replaced.
Additional Manufacturer Narrative
This issue was caused by operator error.To resolve it, the corrective action will involve resetting the settings in the service software.No harm to patients or users.

• Brand Name: NL4100
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): SAMSUNG HME AMERICA, INC.; 14 electronics ave; danvers MA 01923
• Manufacturer (Section G): SAMSUNG HME AMERICA, INC.; 14 electronics ave; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923
• MDR Report Key: 25225284
• Report Number: 3004938766-2026-00024
• Device Sequence Number: 9801791
• Product Code: JAK
• UDI-Device Identifier: 10815411020533
• UDI-Public: (01)10815411020533(11)240628
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: NL4100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown