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Health Canada Medical devices

Aquac Uno H Reverse Osmosis System - Main Unit

Issued November 25, 2022
Issue
The reason for this recall is to inform the operators and users of one Aquac Uno H Reverse Osmosis System of a field safety corrective action due to the possibility of missing ferrite cores in the internal network cable of the device. To meet the requirements of IEC 60601-1 and IEC 60601-1-2 standards, two ferrite cores must be attached to the network cable and the cable routing of the internal network cable must be positioned correctly. Recall start date: November 14, 2022
Hazard description
Performance
Product
Product name
Aquac Uno H Reverse Osmosis System - Main Unit
Reference
ID
RA-72215