Z-1971-2023Class II

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532...

Name: Z-1971-2023 Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532...
Creator: Ellex Medical Pty Ltd.
Published: 2023-03-16
License: https://open.fda.gov/license/

Ellex Medical Pty Ltd / initiated 2023-03-16 / Open, Classified

FDA source

Ellex Medical Pty Ltd. began a recall of Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G on 2023-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1971-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-16
Posted: 2023-06-27
Recalling firm: Ellex Medical Pty Ltd
Product: Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Product code: HQF Laser, Ophthalmic
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.
FDA root cause: Radiation Control for Health and Safety Act
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].
Quantity in commerce: 57 systems in total (6 units shipped to United States)
Distribution: US nationwide/ Worldwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1971-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1971-2023	Class II	Ongoing	FDA Mandated	2023-07-05	2023-06-27

Product code HQF

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)