Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
FDA Recall Z-2191-2013 · Posted 2013-09-11
Recalling FirmLumenis, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2013-08-19
Date Terminated2013-12-19
Product Quantity3 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distributed in the states of NJ, PA, and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.