Recall Z-1030-2013 ยท GYC Electrode, Cortical
Integra Burlington MA, Inc.
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
| Date | Apr 1, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Integra initiated a voluntary recall on March 18, 2013 by providing written notification to consignees either by traceable courier service or traceable emails regarding the correction that Integra records indicate have an OCS2 since it was introduced to the market in 2007. The consignee notification: Advised of the nature of the issue and to immediately stop using the headphone jack while using the OCS2. Requested identification by S/N any OCS2's they have, and complete / return the Acknowledgment Return Form. Advised that Integra will contact the consignee to schedule a time / date to correc |
| Quantity | 371 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924226 | OJEMANN CORTICAL STIMULATOR Radionics, Inc., Apr 21, 1993 |