FDA-Device2022-08-03Class II

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

Fresenius Medical Care Holdings, Inc.
Hazard

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

Sold states
US Nationwide distribution.
Affected count
277 units
Manufactured in
920 Winter St Bld 950, Waltham, MA, United States
Products
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2022

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