Z-1794-2012Class II

PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system...

Name: Z-1794-2012 PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system...
Creator: Plasma Surgical Inc.
Published: 2012-04-27
License: https://open.fda.gov/license/

Plasma Surgical Inc. / initiated 2012-04-27 / Terminated / root cause: manufacturing process

FDA source

Plasma Surgical Inc. began a recall of PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed... on 2012-04-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1794-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-27
Posted: 2012-06-11
Terminated: 2012-11-01
Recalling firm: Plasma Surgical Inc.
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Plasma Surgical, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 27, 2012 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their physical inventory; locate and quarantine or remove from service all identified product; and complete and return the attached CUSTOMER RESPONSE FORM via fax to designated persons at: (404) 678-4395 or mail to: Plasma Surgical Inc., 1125 Northmeadow Parkway, Suite 100, Roswell, Georgia 30076 (even if they no longer have any of the product in their inventory). A Plasma Surgical Representative will contact the customers to arrange for the return of the products and product replacement, should they have any of the physical inventory (product). Should you have any queries concerning this matter, please do not hesitate to contact, Vice President of Sales and Marketing, [email protected] or call (678) 578-4390.
Quantity in commerce: 36 units
Distribution: Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Product codes and lots: Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1794-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-11

Product code GEI

K080197Class IIPlasmajet Neutral Plasma Surgery SystemPlasma Surgical, Ltd. / cleared 2008-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)