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.
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: 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
- 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 →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25