Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapp
FDA device recall Z-1030-2013 · posted 2013-04-01 · Terminated
Recall details
- Recalling firm
- Integra Burlington MA, Inc.
- 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.
- Action taken
- 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 correct the OCS2's they have identified. Questions, contact service hotline at 1-888-772-7378.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GYC
- Quantity affected
- 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, Netherland
- Date initiated
- 2013-03-18
- Date posted
- 2013-04-01
- Date terminated
- 2014-02-25
- Location
- Burlington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OJEMANN CORTICAL STIMULATOR (K924226) | Radionics, Inc. | 1993-04-21 |