Recall Z-1971-2023 ยท HQF Laser, Ophthalmic
Ellex Medical Pty Ltd.
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
| Date | Jun 27, 2023 (initiated Mar 16, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Ellex Safety Bulletin is the customer notification letter. Ellex will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Ellex-Lumibird representative or email us on eservice@ellex.com. |
| Quantity | 57 systems in total (6 units shipped to United States) |
| Distribution | US nationwide/ Worldwide Distribution |
| FDA record | Open on fda.gov |