PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral

FDA device recall Z-1794-2012 · posted 2012-06-11 · Terminated

Recall details

Recalling firm

Plasma Surgical Inc.

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.

Action taken

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, imawhinney@plasmasurgical.com or call (678) 578-4390.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GEI

Quantity affected

36 units

Distribution

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

Date initiated

2012-04-27

Date posted

2012-06-11

Date terminated

2012-11-01

Location

Roswell, GA

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