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Open, Classified

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

FDA Recall Z-1971-2023 · Posted 2023-06-27

Recalling FirmEllex Medical Pty Ltd.
Recall StatusOpen, Classified
Product CodeHQF
Date Initiated2023-03-16
Product Quantity57 systems in total (6 units shipped to United States)

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.

Firm Action

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].

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US nationwide/ Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081565INTEGRE PRO, MODEL L2RYEllex Medical Pty, Ltd. · 2008-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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