Leveen Needle Electrode

• • Terminated Z-0079-2013 FDA Class II ·initiated 17 Sep 2012

  Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.

• 8 recalls, same reason

  • Terminated Z-1913-2008 FDA Unclassified (pre-2012) ·initiated 30 Apr 2008
  • Terminated Z-1915-2008 FDA Unclassified (pre-2012) ·initiated 30 Apr 2008
  • Terminated Z-1914-2008 FDA Unclassified (pre-2012) ·initiated 30 Apr 2008
  • Terminated Z-1916-2008 FDA Unclassified (pre-2012) ·initiated 30 Apr 2008
  • Terminated Z-2093-2008 FDA Unclassified (pre-2012) ·initiated 1 Oct 2007
  • Terminated Z-2094-2008 FDA Unclassified (pre-2012) ·initiated 1 Oct 2007
  • Terminated Z-2092-2008 FDA Unclassified (pre-2012) ·initiated 1 Oct 2007
  • Terminated Z-2091-2008 FDA Unclassified (pre-2012) ·initiated 1 Oct 2007

  The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.

• 2 recalls, same reason

  • Terminated Z-1542-05 FDA Unclassified (pre-2012) ·initiated 29 Jul 2005
  • Terminated Z-1541-05 FDA Unclassified (pre-2012) ·initiated 29 Jul 2005

  Firm has received complaints of extended ablation times, lack of roll-off and patient burns.

510(k) Number

K982556 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESU

• Radiotherapeutics Rf Generator Model Rf-1000

  Class II

  FDA 510(k) K955144 Active Cleared 7 Apr 1996

• MR Compatible Leveen Needle Electrode

  Class II

  FDA 510(k) K982854 Active Cleared 10 Nov 1998

• Leveen Needle Electrode

  Class II

  FDA 510(k) K000032 Active Cleared 30 Mar 2000

• Radiotherapeutics Rf 3000 Radiofrequency Generator

  Class II

  FDA 510(k) K000241 Active Cleared 14 Apr 2000

• Radiotherapeutics Rf-2000 Radiofrequency Generator

  Class II

  FDA 510(k) K981672 Active Cleared 17 Jul 1998

• Sensor Sheath TS1

  Class II

  FDA 510(k) K962386 Active Cleared 20 Aug 1996

See all devices from Radiotherapeutics Corp. →