Z-1030-2013 Class II Terminated
FDA device recall Z-1030-2013 was initiated by Integra Burlington MA, Inc. on March 18, 2013 and is designated Class II. 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 b… The recall status is terminated (terminated February 25, 2014). Affected quantity: 371 units.
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