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Ellex Medical Pty Ltd.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ellex Medical Pty Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-05FDA-DeviceClass IIIntegre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
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.
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