Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode — Class II medical device recall Z-2172-2017
Terminated recall by Laserex Systems Inc., reported 2017-06-14. It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was d
| Recall number | Z-2172-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Laserex Systems Inc., EDEN PRAIRIE, MN, United States |
| Recall initiated | 2017-04-04 |
| Classified | 2017-06-06 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2017-07-31 |
| Quantity | 83 |
| Serial numbers | 0010, 0095 |
Product
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
Reason for recall
It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.
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-2172-2017. 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.