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CORTAC®
PMT CORPORATION · Model 2111TX-10-095 · UDI-DI 00650551061663
GYC
Prescription
1
510(k) clearances
115
Adverse events
6
Recalls
30
Facilities
Description
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 10 CONTACT, 2X5, CLOVERLEAF, CONTACT #1 RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-18 | Ad-Tech Medical Instrument Corporation | Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they |
| 2013-03-18 | Integra Burlington MA, Inc. | 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, |
| 2012-12-18 | Ad-Tech Medical Instrument Corporation | The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture an |
| 2011-10-05 | CareFusion 209 Inc. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annot |
| 2011-10-05 | CareFusion 209 Inc. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annot |
| 2011-10-05 | CareFusion 209 Inc. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annot |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.