Agency classClass IIOur severity:High FDA (Devices)·Z-0992-2022·Announced 2022-05-04

PrisMax System software causes unalerted treatment parameter reversion

The PrisMax System may revert custom treatment parameters to default values without notifying the operator when the Same Patient function is used. This could cause patients to receive unintended treatment settings.

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 recall with no reported hospitalizations, injuries, or deaths. The software anomaly creates a risk that patients could receive unintended treatment parameters, but the hazard remains theoretical with no confirmed adverse events. Per the rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Baxter Healthcare Corporation is recalling the PrisMax System (Product Code 955724), a medical device used for continuous renal replacement therapy, due to software anomalies in its parameter handling. When an operator enters non-default values for the Gain/Loss Limit or Return Pressure Drop Limit (RDL) and initiates therapy using the Same Patient function, the system will revert these parameters to their default values.

The PrisMax System interface will display the original custom values once treatment is restarted, but the system provides no alert to notify the operator that the parameters have been changed. The RDL value will revert immediately upon selecting Same Patient, while the Gain/Loss Limit value will revert when the patient's weight or hematocrit is changed during treatment.

The affected devices, totaling 296 units, were distributed worldwide including to the United States and to facilities in Canada, Mexico, Brazil, and numerous countries in Europe, Asia, the Middle East, and Oceania. Healthcare providers using this equipment should verify that operators are aware of this anomaly and establish procedures to confirm treatment parameters are correctly set at each therapy initiation.

The recalled product

Product: PrisMax System, Product Code 955724
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis / Continuous Renal Replacement Therapy
Hazard: software-defect
incorrect-parameter
lack-of-alert
Affected units: 296

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 07332414126018
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

See all →

Moderate
Baxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Severe
Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16

Same hazard · software defect