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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROLOGICA CORPORATION NL4000; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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NEUROLOGICA CORPORATION NL4000; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number NL4000
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2023
Event Type  malfunction  
Manufacturer Narrative
Based on the investigation completed by service team, an issue was found during high-speed rotation, the tension pulley for the main belt separated from the motor, damaging parts of the gantry.
 
Event Description
The customer reported a loud crash during the patient scan when the gantry was rotating.During high-speed rotation, the pinch wheel split and caused deep scars on the groove, while also breaking a bracket.
 
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Brand Name
NL4000
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
NEUROLOGICA CORPORATION
14 electronics avenue
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 Key18111742
MDR Text Key327889214
Report Number3004938766-2023-00025
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 11/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNL4000
Device Catalogue Number0-NL4000-001
Was Device Available for Evaluation? No
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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