Date Initiated by Firm |
January 17, 2006 |
Date Posted |
May 04, 2006 |
Recall Status1 |
Terminated 3 on May 04, 2006 |
Recall Number |
Z-0842-06 |
Recall Event ID |
35221 |
510(K)Number |
K050673 k051359
|
Product Classification |
Leukotome - Product Code GXE
|
Product |
Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300 |
Code Information |
Serial Number: SN 9998; 9914-0300-0001 through 9914-0300-0058 |
Recalling Firm/ Manufacturer |
Candela Laser Corporation 530 Boston Post Rd Wayland MA 01778-1833
|
For Additional Information Contact |
Edward Gramer 508-358-7637
|
Manufacturer Reason for Recall |
Handle fires even when the finger is off the switch
|
FDA Determined Cause 2 |
Other |
Action |
Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system. |
Quantity in Commerce |
59 units |
Distribution |
Nationwide
Foreign: Canada, Spain, Japan, Germany, France, Switzerland |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GXE and Original Applicant = CANDELA CORP.
|