Recall Z-1794-2012— Plasma Surgical Inc.

Name: FDA recall Z-1794-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-27

Class II · Terminated

Class II FDA medical device recall by Plasma Surgical Inc., initiated 2012-04-27, terminated 2012-11-01. It names one FDA 510(k) clearance: K080197. Product: PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.. Reason: Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use..

Recalling firm: Plasma Surgical Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-27
Terminated: 2012-11-01
Firm location: Roswell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K080197 — PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMPlasma Surgical, Ltd.·cleared 2008-06-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.

Reason for recall

Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.