FDA Device recall Z-2191-2013
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053 by Lumenis, citing lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2191-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-19 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lumenis |
| Distribution | IL, NJ, PA |
Product
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Reason
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Identifiers
| code_info | Model: GA-0025020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2191-2013%22
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