Health product recall

Aquac Uno H Reverse Osmosis System - Main Unit

Last updated

Summary

Product
Aquac Uno H Reverse Osmosis System - Main Unit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Aquac Uno H Reverse Osmosis System - Main Unit

9CHS2905

F00004561

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

Additional information

Details
Original published date: 2022-11-25
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Fresenius Medical Care AG & Co. KGAA

Else-Kroner-Strasse 1, Bad Homburg, Germany, 61352

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72215