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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Life Sciences Ojemann Cortical Stimulator

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 Class 2 Recall
Integra Life Sciences Ojemann Cortical Stimulator
see related information
Date Posted April 01, 2013
Recall Status1 Terminated on February 25, 2014
Recall Number Z-1030-2013
Recall Event ID 64665
Premarket Notification
510(K) Number
K924226 
Product Classification Electrode, Cortical - Product Code GYC
Product Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Code Information Serial Number Range: 1010 through 1380
Recalling Firm/
Manufacturer
Integra Burlington MA, Inc.
22 Terry Ave
Burlington, Massachusetts 01803-2516
For Additional Information Contact Same
781-272-1233
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GYC and Original Applicant = RADIONICS, INC.
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