Z-0838-2009

NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue

Name: Z-0838-2009 NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue
Creator: Neurotherm, Inc.
Published: 2008-07-28
License: https://open.fda.gov/license/

Neurotherm, Inc. / initiated 2008-07-28 / Terminated / root cause: labeling and UDI

FDA source

Neurotherm, Inc. began a recall of NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue on 2008-07-28. The reason FDA records is "Distal tip may detach from the probe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0838-2009
Status: Terminated
Initiated: 2008-07-28
Posted: 2009-01-13
Terminated: 2009-09-24
Recalling firm: Neurotherm, Inc.
Product: NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Distal tip may detach from the probe
Root cause tag: labeling and UDI
FDA 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 in commerce: 71 units
Distribution: CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,
Product codes and lots: Lot numbers: 080630- 1 B and 080630- 1 C Exp. June 2011

Product code GXI

K011387Class IINeurotherm, Model Jk4Eurolink, LLC / cleared 2001-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)