| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00141-1 |
| Product Name/Description |
Natus NicoletOne 32Ch Ambulatory EEG Record System
Serial Number: MBR160952
ARTG Number: 294968 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The supplier, Natus has discovered a scenario that incorrectly allows customers using NicVue to import an ambulatory exam into a patient for whom the exam was not started.
In the event that after starting an ambulatory exam, the recorder application does not shutdown correctly, an empty exam file is left in the patient exam list in NicVue. With this empty exam file present, no internal check is done to ensure the patient ID on the Ambulatory’s SD card matches the selected patient in NicVue, resulting in the exam on the SD card being imported into the patient record that is currently selected in NicVue. The register.exe application will bypass the patient ID check on the card of the selected patient and allow the exam to be registered into any selected patient. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
LifeHealthcare is advising users to ensure the recorder is only shutdown via the Recorder UI, either from the File menu or the X button. If the issue occurs, the empty exam can be deleted from NicVue prior to importing the ambulatory exam.
LifeHealthcare will be conducting training for relevant staff regarding this issue, and providing users with an updated copy of the Instructions for Use.
This action has been closed out on 30/10/2018 |
| Contact Information |
02 8114 1553 - Customer Service Support |