Recall Z-0838-2009 ยท GXI Probe, Radiofrequency Lesion
Neurotherm, Inc.
NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
| Date | Jan 13, 2009 (initiated Jul 28, 2008) |
| Status | Terminated |
| Reason | Distal tip may detach from the probe |
| Root cause | Labeling design |
| Action | NeuroTherrn sales representatives were notified telephonically or through e-mail. End users were notified through visits by NeuroTherm sales representatives on 7/28/08 and 8/15/08. For questions, please contact NeuroTherm, Inc. at 1-978-777-3916. |
| Quantity | 71 units |
| Distribution | CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011387 | NEUROTHERM, MODEL JK4 Eurolink, LLC, Sep 6, 2001 |