Health product recall

Integre Pro

Last updated

Summary

Product
Integre Pro
Issue
Medical devices - Performance
What to do

Contact CLARION MEDICAL TECHNOLOGIES INC

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

Integre Pro

IPG0542
SN: 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies

Ellex Medical Pty Ltd

3-4 Second Avenue, Mawson Lakes, South Australia, Australia, 5095

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-73457

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe