Health ProductsType I recall

Microdeep Depth Electrode

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Microdeep Depth Electrode
Issue: Medical devices - Performance
What to do: Retrieve and isolate the affected products.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Microdeep Depth ElectrodeAll lots.D08-05AM
Microdeep Depth ElectrodeAll lots.D08-10AM
Microdeep Depth ElectrodeAll lots.D08-15CM
Microdeep Depth ElectrodeAll lots.D08-15AM

Issue

A manufacturing defect has been identified in the caps used in certain Dixi Medical devices. Although the cap is screwed onto the guiding screw, it is possible for the electrodes to slip inside. this indicates that the clamping function provided by the screw may not be fully effective, potentially compromising the safe positioning of the device. Customers are requested to isolate the affected devices. Recall start date: July 30, 2025

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