Aquac Uno H Reverse Osmosis System - Main Unit
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
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