Date Initiated by Firm |
August 19, 2013 |
Date Posted |
September 11, 2013 |
Recall Status1 |
Terminated 3 on December 19, 2013 |
Recall Number |
Z-2191-2013 |
Recall Event ID |
66133 |
510(K)Number |
K111213
|
Product Classification |
Powered laser surgical instrument - Product Code GEX
|
Product |
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053.
Intended for use in the treatment of ocular pathology. |
Code Information |
Model: GA-0025020 |
Recalling Firm/ Manufacturer |
Lumenis, Inc. 3959 W 1820 S Salt Lake City UT 84104
|
For Additional Information Contact |
Mr. Rick Gaykowski 801-656-2690
|
Manufacturer Reason for Recall |
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
|
FDA Determined Cause 2 |
Software design |
Action |
Customer's were notified via letter on 8/19/13. Service visits to consignees were scheduled with anticipated completion on 8/26/13 to replace the control board. Consignee monitoring was performed by use of return reply verification tracking cards returned by the Lumenis service engineer after completion of CPU board replacement. |
Quantity in Commerce |
3 units |
Distribution |
Distributed in the states of NJ, PA, and IL. |
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 = GEX and Original Applicant = LUMENIS INC.
|