OBM - Digital Acquisition Box
Last updated
Summary
Product
OBM - Digital Acquisition Box
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
OBM - Digital Acquisition Box |
S/N: 001 through OBM00002H3613 |
OBM00002 |
Issue
Natus has 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.
Recall Start Date: May 5, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
2568 Bristol Circle, Oakville, Ontario, Canada, L6H 5S1
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-77455
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