Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre… recallZ-1971-2023 · Ellex Medical Pty Ltd. · initiated Mar 16, 2023
Class II Open, Classified All recalls posted in June 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ellex Medical Pty Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Radiation Control for Health and Safety Act
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1971-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 16, 2023
- Posted by the FDA
- Jun 27, 2023
- Recalling firm
- Ellex Medical Pty Ltd.
- Quantity
- 57 systems in total (6 units shipped to United States)
- Product code
- HQF
- FDA submissions
- K081565, K142398
- Distribution
- US nationwide/ Worldwide Distribution
Product description
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Code information (models, lots, serial numbers)
Serial Nos., UDI IPY0374, (01) 0 9342395 00012 0 ISRY0242, (01) 0 9342395 00015 1 ISG0370, (01) 0 9342395 00024 3 IPG0539, (01) 0 9342395 00009 0 BG1190
Other devices under the same FDA submission
2 devices cleared under K081565, K142398 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Integre Pro Scan Yellow LP6YEllex Medical Pty Ltd · Laser, Ophthalmic1 report
- Integre Pro Scan Green LP6GEllex Medical Pty Ltd · Laser, Ophthalmic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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