Product Wiki · Recalls · Health Canada — Medical Devices

Aquac Uno H Reverse Osmosis System - Main Unit — recall 72215

Health Canada — Medical Devices · Canada · 2022-11-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
72215
Date of alert
2022-11-25
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aquac-uno-h-reverse-osmosis-sy

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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