Integre Pro
Brand(s)
Summary
Contact CLARION MEDICAL TECHNOLOGIES INC
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Integre Pro |
IPG0542 |
LP5532 |
Issue
Ellex was recently made aware of a potential safety issue impacting a small number of Integre Pro/Integre Pro Scan lasers . This was reported as a single event during servicing with no injury; when using a laser-indirect-ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may exit through the slit lamp output port (SDS) and get emitted from the objective lens when the laser is fired. The cause was traced to an incorrect assembly of a sub-module in the laser cavity system.
Recall start date: March 13, 2023
Additional information
Details
Ellex Medical Pty Ltd
3-4 Second Avenue, Mawson Lakes, South Australia, Australia, 5095
Get notified
Receive notifications for new and updated recalls and alerts by category.