Prototype — internal review only. Not in sitemap, not indexed.

Recall notice

The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy

Brand: BAXTER HEALTHCARE CORPORATION · EAN: 0085412639499

Recall details [source]

• Source: U.S. FDA — Medical Devices
• Source ID: Z-0215-2022
• Recall date: 2021-09-28T22:00:00+00:00
• Recall product name (as filed): Hemodialysis Delivery System, Software Version 2.x.

Reason

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

Verify on U.S. FDA — Medical Devices → https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Sources: U.S. FDA — Medical Devices · last fetched: 2026-05-31T11:16:26.990000+00:00

This page is an index of public regulatory data. It is not medical, legal, or safety advice. If the product is in your possession, follow the issuing agency's guidance and consult the relevant specialist.

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