| TGA Action ID |
RC-2025-RN-00463-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympic Brainz Monitor (Digital Acquisition Box)
Part Number: OBM00002
UDI Number: 00382830010825
Manufacture Dates: Jan-2012 - Dec 2023
Serial Numbers: 001 - OBM00002H3613
Please Note: earlier version serial numbers did not contain the sequence of OBM. |
| ARTG Number |
449466 |
| Unique Device Identifier (UDI) |
038283NA00019E8 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Natus become aware of two complaints related to the Olympic Brainz Monitor where the electrode placement labels on the DATA ACQUISITION BOX (DAB) were on backwards.
This labelling error may lead to a use error where the electrodes are connected incorrectly, causing the left and right channels to be misaligned. As a result, the recorded data may be misinterpreted, potentially leading to a misdiagnosis of seizure location in neonates monitored with this device.
|
| Instructions for Customers/Users |
Customers should check their Olympic Brainz Monitor stock and determine if their devices have the incorrect label orientation present.
If the product labelling is incorrect customers should immediately cease use of the affected product and quarantine until they receive the shipping instructions from Natus to return it.
A replacement device(s) will be made available to customers at no cost, upon completion of the completed Customer Reply Form contained in the customer letter.
This action has been closed out on 12/08/2025. |
| Action Commencement Date |
12/05/2025 |
| Responsible Entity |
|
| Contact Information |
FCA@Natus.com |