FDA Medical Device Recalls (openFDA)
Lumenis, Inc.: Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
- Recall number
- Z-2191-2013
- Recalling firm
- Lumenis, Inc.
- Product
- Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
- Status
- Terminated
- Initiated
- 2013-08-19
- Posted
- 2013-09-11
- Terminated
- 2013-12-19
- 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.
- Lot, serial or model codes
- Model: GA-0025020
- 510(k) numbers
- ["K111213"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1720381
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28