FDA-Device2025-09-03Class II
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
VANTIVE US HEALTHCARE LLC
Hazard
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Sold states
Worldwide
Affected count
4772 units
Manufactured in
510 Lake Cook Rd, Deerfield, IL, United States
Products
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2025Don't want to check this manually?
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