Vision One Laser System Model GA-0025020 — Class II medical device recall Z-2191-2013
Terminated recall by Lumenis, Inc., reported 2013-09-18, distributed in IL, NJ, PA. Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser
| Recall number | Z-2191-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumenis, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2013-08-19 |
| Classified | 2013-09-11 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2013-12-19 |
| Distributed | IL, NJ, PA |
| Quantity | 3 units |
| Serial numbers | 10050, 10051, 10053 |
| Model numbers | GA-0025020 |
Product
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2191-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.