Device product

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

Z-2437-2025

July 28, 2025

Class II

Product summary

Firm: VANTIVE US HEALTHCARE LLC
Event: Event 97233
Status: Ongoing
Classification: Class II
Quantity: 4772 units
Official record key: device-enforcement:Z-2437-2025

Official wording

Reason: 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

Code information: UDI 00085412639499, All Serial Numbers

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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