Reported Apr 10, 2013 · Terminated
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation…
Integra Burlington MA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra Burlington MA, Inc. · 22 Terry Ave · Burlington, MA · 01803-2516
Is this the product you have?
- Integra Ojemann Cortical Stimulator
- Product / Catalogue NoOCS2. Intended for intraoperative cortical stimulation mapping procedures
- Lot codes and dates
- Serial Number Range1010 through 1380
- Amount recalled
- 371 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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