MAUDE Adverse Event Report: Samsung HME America, Inc. NL4000; Computed Tomography X-ray System

Model Number	NL4000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Other

• Brand Name: NL4000
• 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: 50870847
• Report Number: 3004938766-2026-00043
• Device Sequence Number: 16120874
• Product Code: JAK
• UDI-Device Identifier: 10815411020267
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170238
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Model Number: NL4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2014
• 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