Agency classClass IIOur severity:High FDA (Devices)·Z-0993-2022·Announced 2022-05-04

PrisMax System software anomaly affects therapy parameter settings

The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.

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: FDA Class II device with a software defect creating risk of improper therapy parameters. No injuries, hospitalizations, or illnesses reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

The PrisMax System, a renal replacement therapy device manufactured by Baxter Healthcare Corporation, is subject to a worldwide recall affecting 3,513 units due to software anomalies in its parameter-management function.

The defect occurs when an operator uses the "Same Patient" function after entering non-default values for either the Patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL). The system silently reverts these parameters to their default values without alerting the operator. The display will show the original values once treatment restarts, but this absence of notification means the operator may not realize the settings have changed.

This defect creates a risk that patients may receive therapy with unintended parameter settings, potentially affecting treatment adequacy. The affected units were distributed worldwide, including the United States, Canada, Mexico, Brazil, and numerous European, Asian, and Pacific countries.

Healthcare facilities and operators using the PrisMax System should review their device settings carefully and verify whether this anomaly may have affected patient care.

The recalled product

Product: PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis / Renal Replacement Therapy
Hazard: software-defect
parameter-reversion
interface-error
Affected units: 3,513

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 (7)

a) 955558
UDI 07332414124359
b) 955627
UDI 07332414124700
c) 955701
UDI 07332414125844
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 defect