MAUDE Adverse Event Report: NEUROLOGICA CORP NL4100; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL4100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An issue during scanning caused a reset to home screen.The scanner was not connected to the workstation, and the customer either changed the start or end scan position, which resulted in an exception.After reconnecting the scanner by rebooting the workstation, the system functioned normally.Daily calibration was completed successfully.It was a user-driven issue not a product malfunction.No harm to the patient or users.
Event or Problem Description
An issue during scanning was causing the device to reset to the home screen, resulting in potential delay in patient treatment.

• Brand Name: NL4100
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORP; 14 electronics ave; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORP; 14 electronics ave; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923
• MDR Report Key: 23799906
• Report Number: 3004938766-2025-00034
• Device Sequence Number: 15800143
• Product Code: JAK
• UDI-Device Identifier: 10815411020533
• UDI-Public: (01)10815411020533(11)250725
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242811
• 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): 12/12/2025

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
• Device Catalogue Number: 0-NL4100-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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