Cusa Selector Nxt Ultrasonic Tissue Ablation System

• • Terminated Z-0491-2015 FDA Class II ·initiated 29 Sep 2014

  Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.

• • Terminated Z-2585-2011 FDA Unclassified (pre-2012) ·initiated 2 May 2011

  The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration.

• 2 recalls, same reason

  • Terminated Z-2638-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010
  • Terminated Z-2637-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010

  A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess aspiration that requires medical intervention.

510(k) Number

K081459 ↗

FDA Product Code

LFL

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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