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Ellex Medical Pty Ltd. recalls Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics
Recalled July 5, 2023 · FDA recall Z-1971-2023 · Ellex Medical Pty
Hazard
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. · FDA Class II
Units
57 systems in total (6 units shipped to United States)
Sold at
US nationwide/ Worldwide Distribution
Description
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
Manufacturer(s)
Ellex Medical Pty Ltd.
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →