BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1794-2012 · Initiated April 27, 2012

    Recall

    Recall Number
    Z-1794-2012
    Event Number
    61951
    Firm
    Plasma Surgical Inc.
    FEI Number
    3004754983
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 27, 2012
    Posted
    June 11, 2012
    Terminated
    November 1, 2012
    Address
    1009 Mansell Rd, Ste F, Roswell, GA, 30076-4806

    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

    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.

    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.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.

    Quantity

    36 units