FDA-Device2024-06-19Class II
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Fresenius Medical Care Holdings, Inc.
Hazard
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
Sold states
US Nationwide distribution in the states of AL, IN, AK, WI.
Affected count
4 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2141-2024Don't want to check this manually?
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