Integre Pro Yellow LP561 recalled over fire hazard

Recall date

March 16, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ellex Medical Pty Ltd. recalls Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics…

Recall number

Z-1971-2023

FDA classification

Class II

Brand / firm

Ellex Medical Pty Ltd.

Sold / distributed

US nationwide/ Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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