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

Model Number	NL4100
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had to be rescanned due to artifact in the images.
Additional Manufacturer Narrative
There were artifacts in the image requiring the rescan of the patient.The corrective measure for the issue was to replace the detector module.The service team ran the daily calibration, qa check, and water phantom check with no artifact.There was no harm to the patient or user.Any additional information received on this incident will be reported in a follow-up mdr.

• 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: 22416632
• Report Number: 3004938766-2025-00020
• Device Sequence Number: 21007525
• Product Code: JAK
• UDI-Device Identifier: 10815411020533
• UDI-Public: (01)10815411020533(11)250328
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Repair
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: 06/08/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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