NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
FDA device recall Z-0838-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Neurotherm, Inc.
- Reason for recall
- Distal tip may detach from the probe
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GXI
- Quantity affected
- 71 units
- Distribution
- CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,
- Date initiated
- 2008-07-28
- Date posted
- 2009-01-13
- Date terminated
- 2009-09-24
- Location
- Middleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROTHERM, MODEL JK4 (K011387) | Eurolink, LLC | 2001-09-06 |