Z-1030-2013Class II

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

Name: Z-1030-2013 Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical...
Creator: Integra Burlington MA, Inc.
Published: 2013-03-18
License: https://open.fda.gov/license/

Radionics, Inc. / initiated 2013-03-18 / Terminated / root cause: design

FDA source

Integra Burlington MA, Inc. began a recall of Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures on 2013-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1030-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Posted: 2013-04-01
Terminated: 2014-02-25
Recalling firm: Radionics, Inc.
Product: Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Product code: GYC Electrode, Cortical
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Serial Number Range: 1010 through 1380

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1030-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01

Product code GYC

K924226Class IIOjemann Cortical StimulatorRadionics, Inc. / cleared 1993-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)