Product Wiki · Recalls · U.S. FDA — Device Enforcement

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G — recall Z-1971-2023

U.S. FDA — Device Enforcement · Australia · 2023-03-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1971-2023
Date of alert
2023-03-16
Country / jurisdiction
Australia
Risk level
Class II
Risk type
recall
Brand
Ellex Medical Pty Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.