NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
This recall has been terminated (originally issued January 13, 2009).
- Company
- Neurotherm, Inc.
- Recall Initiated
- July 28, 2008
- Posted
- January 13, 2009
- Terminated
- September 24, 2009
- Recall Number
- Z-0838-2009
- Quantity
- 71 units
- Firm Location
- Middleton, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Distal tip may detach from the probe
Distribution
CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,
Lot / Code Info
Lot numbers: 080630- 1 B and 080630- 1 C Exp. June 2011
Root Cause
Labeling design
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.