Hemodialysis delivery system may trigger false alarms causing repeated priming cycles
The PrisMax V2-US hemodialysis delivery system may produce false air-detection alarms during priming due to low deaeration chamber levels, resulting in multiple unnecessary priming cycles.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The identified hazard is a documented operational issue—false alarms causing repeated device cycles—rather than explicit patient harm. Without direct evidence of patient risk in the source text, this scores as Moderate per the rubric.
Plain-English summary
VANTIVE US HEALTHCARE LLC is recalling 4,772 units of the PrisMax V2-US Hemodialysis Delivery System (Product Codes: 955626, 955558, 955627, 955701). All serial numbers are included in this worldwide recall.
The recalled units may generate a false alarm—System Alarm T2309: 'Air Detected in Prime'—when deaeration chamber levels are low during post-priming tests. When triggered, this false alarm causes the system to automatically initiate multiple additional priming cycles.
The condition stems from low deaeration chamber levels at post-priming stages, which can be misinterpreted by the device's detection system as the presence of air in the prime line, leading to the erroneous alarm and cascading priming repetitions.
The recalled product
- Product
- PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Hazard
- false-alarm
- system-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 00085412639499
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
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