Ellex Medical Pty Ltd.: Medical Device Recall in 2023 - (Recall #: Z-1971-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 16, 2023

Date Posted: July 5, 2023

Recall Number: Z-1971-2023

Event ID: 92532

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.

Status: Ongoing

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

Code Information:

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

Distribution Pattern:

US nationwide/ Worldwide Distribution

Voluntary or Mandated:

FDA Mandated