# FDA recall Z-1971-2023

> **Ellex Medical Pty Ltd.** · Class II · device recall initiated 2023-03-16.

## Product

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532  Spare, Optics Bench V2, L2G/LP6G

## Reason for recall

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.

## Distribution

US nationwide/ Worldwide Distribution

## Key facts

- **Recall number:** Z-1971-2023
- **Recalling firm:** Ellex Medical Pty Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-16
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Mawson Lakes, N/A, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1971-2023

## Citation

> AI Analytics. FDA recall Z-1971-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1971-2023. Source: US FDA. Licensed CC0.

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