Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Reported: July 5, 2023 Initiated: March 16, 2023 #Z-1971-2023
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
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.
Details
- Recalling Firm
- Ellex Medical Pty Ltd.
- Units Affected
- 57 systems in total (6 units shipped to United States)
- Distribution
- US nationwide/ Worldwide Distribution
- Location
- Mawson Lakes, N/A
Frequently Asked Questions
What product was recalled? ▼
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G. Recalled by Ellex Medical Pty Ltd.. Units affected: 57 systems in total (6 units shipped to United States).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-1971-2023.
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