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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 Recall
Vision One Laser System Model
see related information
Date Posted September 11, 2013
Recall Status1 Terminated on December 19, 2013
Recall Number Z-2191-2013
Recall Event ID 66133
Premarket Notification
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, Utah 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LUMENIS INC.
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