Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics
FDA device recall Z-1971-2023 · posted 2023-06-27 · Open, Classified
Recall details
- Recalling firm
- Ellex Medical Pty Ltd.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- HQF
- Quantity affected
- 57 systems in total (6 units shipped to United States)
- Distribution
- US nationwide/ Worldwide Distribution
- Date initiated
- 2023-03-16
- Date posted
- 2023-06-27
- Location
- Lakes, Mawson, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow (K142398) | Ellex Medical Pty, Ltd. | 2015-07-14 |
| INTEGRE PRO, MODEL L2RY (K081565) | Ellex Medical Pty, Ltd. | 2008-07-02 |