FDA Medical Device Recalls (openFDA)
Neurotherm, Inc.: NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
- Recall number
- Z-0838-2009
- Recalling firm
- Neurotherm, Inc.
- Product
- NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
- Status
- Terminated
- Initiated
- 2008-07-28
- Posted
- 2009-01-13
- Terminated
- 2009-09-24
- 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,
- Lot, serial or model codes
- Lot numbers: 080630- 1 B and 080630- 1 C Exp. June 2011
- 510(k) numbers
- ["K011387"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 3002953813
- Firm city
- Middleton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28