MAUDE Adverse Event Report: SAMSUNG HME AMERICA, INC. NL5000; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL5000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The helical scan failure following a dynamic scan in a bolus tracking protocol was caused by an improper transition state between internal modules.A targeted software fix was implemented via patch, avoiding high-risk system changes and performance delays.Post-installation validation, including air calibration and qa scans, confirmed the issue is resolved and the system is operating reliably.No harm to patients or users.
Event or Problem Description
A helical scan failed immediately following the completion of a dynamic scan during a bolus tracking protocol causing a re-exposure and a delay in the patient's treatment.

• Brand Name: NL5000
• 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 ave; danvers, MA 01923
• MDR Report Key: 24737208
• Report Number: 3004938766-2026-00016
• Device Sequence Number: 9242605
• Product Code: JAK
• UDI-Device Identifier: 10815411020663
• UDI-Public: (01)10815411020663(11)230512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202526
• 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): 03/30/2026

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: NL5000
• Device Catalogue Number: 0-NL5000-002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2023
• 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