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Health Canada Medical devices

Aquac Uno H Reverse Osmosis System - Main Unit

Issued June 27, 2022
Issue
On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been placed correctly during assembly. Instead of routing the cable outside the boundaries of the fuse board, it was routed across the board. Due to this, the cable may get in close contact to the fuse holders. This close contact can cause thermal damage to the outer jacket of the cable and apply the main voltage to the ethernet cable. If the corresponding ethernet socket outside of the device is touched, there is the risk of electrical shock to the user. Recall start date: June 16, 2022
Hazard description
Performance
Product
Product name
Aquac Uno H Reverse Osmosis System - Main Unit
Reference
ID
RA-64315