Recall Z-1971-2023— Ellex Medical Pty Ltd.
Class II · Ongoing
Class II FDA medical device recall by Ellex Medical Pty Ltd., initiated 2023-03-16. It names 2 FDA 510(k) clearances: K142398, K081565. Product: Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G. 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..
- Recalling firm
- Ellex Medical Pty Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-16
- Firm location
- Mawson Lakes, N/A, Australia
510(k) clearances named in this recall
2 on FDA's record- K142398 — Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
- K081565 — INTEGRE PRO, MODEL L2RY
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.