Ellex Medical Pty Ltd. Recall 92532
Description: Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Ellex Medical Pty Ltd. Recall 92532 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1971-2023 |
| Event ID | 92532 |
| Event Description | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G |
| Product Type | Devices |
| Distribution | US nationwide/ Worldwide Distribution |
| Quantity | 57 systems in total (6 units shipped to United States) |
| Recall 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. |
| Device Classification | 20230705 |
| Device Code Info | 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 |
| Center Classification Date | 20230627 |
| Recall Initiation Date | 20230316 |
| Recalling Firm | Ellex Medical Pty Ltd. |
| Initial Notification | N/A |
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