Agency classClass IIOur severity:High FDA (Devices)·Z-0991-2022·Announced 2022-05-04

PrisMax Dialysis System Software Bug Silently Reverts Patient Treatment Parameters

The PrisMax dialysis system has a software bug that silently reverts treatment parameters to default values without notifying operators, affecting 1,253 units worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported hospitalizations or injuries. However, the software anomaly causes critical dialysis treatment parameters to silently revert without operator notification, creating a risk of patient harm. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling the PrisMax System (Product Code 955626) due to a software anomaly. This recall includes all 1,253 units with all serial numbers, distributed worldwide including the United States, Mexico, Brazil, Canada, Australia, and numerous European and Asian countries.

The software defect causes treatment parameters to revert to default values without user notification. When an operator enters a non-default Patient Gain/Loss Limit or Return Pressure Drop Limit (RDL) and activates the Same Patient function, the system reverts these values to defaults without alerting the operator. The RDL resets immediately upon selecting Same Patient, while the Gain/Loss Limit resets when patient weight or hematocrit is changed during treatment. The system does not provide an alert when these changes occur.

This silent reversion of critical dialysis treatment parameters could result in treatment being delivered with unintended settings. Operators should verify that entered parameter values are retained and match intended values before and during treatment. Contact Baxter Healthcare Corporation for further instructions.

The recalled product

Product: PrisMax System, Product Code 955626
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: software-bug
treatment-parameter-reversion
missing-alert
Affected units: 1,253

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)

GTIN 00085412639499
All Serial Numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · software bug