FDAFDA · Food and drugs·Recall number Z-1030-2013
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Published April 10, 2013 · Recall initiated: March 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra Burlington MA, Inc.
- Distributor
- 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 Number Range: 1010 through 1380
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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