FDA-Device2022-09-28Class II
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Fresenius Medical Care Holdings, Inc.
Hazard
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Sold states
US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
Affected count
24 units
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1769-2022Don't want to check this manually?
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