Class II — Lumenis, Inc.
| Recalling firm | Lumenis Be Ltd. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. |
| Quantity | 3 units |
| Distribution | Distributed in the states of NJ, PA, and IL. |
| Initiated | 2013-08-19 |
| Classified | 2013-09-11 |
| Terminated | 2013-12-19 |
| Recall number | Z-2191-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lumenis, Inc. (Z-2191-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66133/
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