Reported Jul 5, 2023 · Ongoing
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics…
Ellex Medical Pty Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ellex Medical Pty Ltd. · 3-4 Second Ave · Mawson Lakes, N/A · N/A
Is this the product you have?
Integre Pro Yellow LP561Integre Pro Yellow LP6RYIntegre Pro Scan Green LP6GIntegre Pro Green LP5532 SpareOptics Bench V2L2G/LP6G
- Lot codes and dates
Serial NosUDI 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
- Amount recalled
- 57 systems in total (6 units shipped to United States)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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