Home / Recalls / Integra Burlington MA, Inc. / Z-1030-2013

Z-1030-2013 Class II Terminated

Recalled by Integra Burlington MA, Inc. — Burlington, MA

Recall Details

Product Type: Devices
Report Date: April 10, 2013
Initiation Date: March 18, 2013
Termination Date: February 25, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 371 units

Product Description

Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.

Code Information

Serial Number Range: 1010 through 1380