Public recall detail

Integre Pro

2023-04-05

medium
Recall Safety notice
Quick summary

Quick summary: Integre Pro. Date: 2023-04-05.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Integre Pro. Date: 2023-04-05.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEllex Medical Pty Ltd
ProductIntegre Pro
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73457

Affected products

ProductIntegre Pro
LotIPG0542 SN: IPG0542
ModelLP5532
Serial numberIPG0542 SN: IPG0542
DescriptionIntegre Pro

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

What you should do

  • Contact CLARION MEDICAL TECHNOLOGIES INC
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Ophthalmology
CompaniesEllex Medical Pty Ltd 3-4 Second Avenue, Mawson Lakes, South Australia, Australia, 5095
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73457
Background{}
CompaniesEllex Medical Pty Ltd 3-4 Second Avenue, Mawson Lakes, South Australia, Australia, 5095
AudiencesHealthcare Industry
Source updated2023-04-05

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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