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U.S. Department of Health and Human Services

Class 2 Device Recall Vision One Laser System Model

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  Class 2 Device Recall Vision One Laser System Model see related information
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.
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