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Terminated

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

FDA Recall Z-0838-2009 · Posted 2009-01-13

Recalling FirmNeurotherm, Inc.
Recall StatusTerminated
Product CodeGXI
Date Initiated2008-07-28
Date Terminated2009-09-24
Product Quantity71 units

Reason for Recall

Distal tip may detach from the probe

Firm 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.

Root Cause

Labeling design

Distribution Pattern

CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011387NEUROTHERM, MODEL JK4Eurolink, LLC · 2001-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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