FDA-Device2025-09-03Class II
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
VANTIVE US HEALTHCARE LLC
Hazard
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
Sold states
Worldwide
Affected count
2449 units
Manufactured in
510 Lake Cook Rd, Deerfield, IL, United States
Products
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2438-2025Don't want to check this manually?
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