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Integre pro
Official notice
5 Apr 2023
Last checked
5 Apr 2023
An official Health Canada notice concerns Integre pro. 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 Published 2023-04-05.
What to do now
Contact CLARION MEDICAL TECHNOLOGIES INC
Recall number
73457
Official notice
2023-04-05
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Ellex Medical, Integre Pro.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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