Class II — Ellex Medical Pty Ltd.
| Recalling firm | Ellex Medical |
|---|---|
| Registered facility | Ellex Medical Pty Ltd (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired. |
| Product | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G |
| Quantity | 57 systems in total (6 units shipped to United States) |
| Distribution | US nationwide/ Worldwide Distribution |
| Initiated | 2023-03-16 |
| Classified | 2023-06-27 |
| Recall number | Z-1971-2023 |
| Initiation | FDA Mandated |
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 — Ellex Medical Pty Ltd. (Z-1971-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92532/
Alerts for Ellex Medical
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.