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Aquac uno h reverse osmosis system - main unit

Official notice

25 Nov 2022

Last checked

25 Nov 2022

Medium riskHealth Canada

An official Health Canada notice concerns Aquac uno h reverse osmosis system - main unit. 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 Published 2022-11-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72215

Official notice

2022-11-25

The hazard

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

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.

Recall Numbers

72215

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Affected products

Product 1

Affected products - Aquac Uno H Reverse Osmosis System - Main Unit, Lot or serial number - 9CHS2905, Model or catalog number - F00004561

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Fresenius Medical Care Kgaa, Aquac Uno H Reverse Osmosis System - Main Unit.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72215

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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