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Integra Burlington MA, Inc. recalls Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation
Recalled April 10, 2013 · FDA recall Z-1030-2013 · Integra Burlington MA
Hazard
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 Class II
Units
371 units
Sold at
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.
Description
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.
Product
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Manufacturer(s)
Integra Burlington MA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →