Recall Z-2191-2013 ยท GEX Powered Laser Surgical Instrument
Lumenis, Inc.
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
| Date | Sep 11, 2013 (initiated Aug 19, 2013) |
| Status | Terminated |
| Reason | Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. |
| Root cause | 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 | 3 units |
| Distribution | Distributed in the states of NJ, PA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111213 | VISION ONE LASER SYSTEM Lumenis, Inc., Jul 25, 2011 |