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

This recall is currently active, issued June 27, 2023. It was issued by Ellex Medical Pty Ltd..

Company

Ellex Medical Pty Ltd.

Recall Initiated

March 16, 2023

Posted

June 27, 2023

Recall Number

Z-1971-2023

Quantity

57 systems in total (6 units shipped to United States)

Firm Location

Mawson Lakes Australia

Official Source

View on FDA website ↗

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

Lot / Code Info

Serial Nos., UDI IPY0374, (01) 0 9342395 00012 0 ISRY0242, (01) 0 9342395 00015 1 ISG0370, (01) 0 9342395 00024 3 IPG0539, (01) 0 9342395 00009 0 BG1190

Root Cause

Radiation Control for Health and Safety Act

Action Taken

Ellex Safety Bulletin is the customer notification letter. Ellex will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Ellex-Lumibird representative or email us on eservice@ellex.com.