FDA Medical Device Recalls (openFDA)
Integra Burlington MA, Inc.: Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
- Recall number
- Z-1030-2013
- Recalling firm
- Integra Burlington MA, Inc.
- Product
- Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
- Status
- Terminated
- Initiated
- 2013-03-18
- Posted
- 2013-04-01
- Terminated
- 2014-02-25
- 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 correct the OCS2's they have identified. Questions, contact service hotline at 1-888-772-7378.
- 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.
- Lot, serial or model codes
- Serial Number Range: 1010 through 1380
- 510(k) numbers
- ["K924226"]
- PMA numbers
- not on file
- Product code
- GYC
- Firm FEI
- 1000120652
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28