FDA-Device2012-06-20Class II
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.
Plasma Surgical Inc.
Hazard
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.
Sold states
Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Affected count
36 units
Manufactured in
1009 Mansell Rd Ste F, Roswell, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2012Don't want to check this manually?
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