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.
What this means for you
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
- Hazard
- software-bug
- treatment-parameter-reversion
- missing-alert
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.
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01