Recall Z-1794-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Plasma Surgical Inc.
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.
| Date | Jun 11, 2012 (initiated Apr 27, 2012) |
| Status | Terminated |
| 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. |
| 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). |
| Quantity | 36 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080197 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM Plasma Surgical, Ltd., Jun 24, 2008 |