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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00467-1
Product Name/Description	Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator) Catalogue number: OCS2 All serial numbers affected ARTG number: 150717
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/05/2013
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	The manufacturer found that if the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
Recall Action	Recall for Product Correction
Recall Action Instructions	Integra is advising users that the device may still be used providing the audio jack is not used. An Integra representative will contact affected customers to arrange for the disabling of the audio jacks and prevent the problem occurring. No reports of this issue have been received from the field.
Contact Information	1300 550 599 - Integra Customer Service