Z-1971-2023 Class II Ongoing
FDA device recall Z-1971-2023 was initiated by Ellex Medical Pty Ltd. on March 16, 2023 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 57 systems in total (6 units shipped to United States).
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- March 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 57 systems in total (6 units shipped to United States)
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.
Distribution Pattern
US nationwide/ Worldwide Distribution
Code Information
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