Baxter Healthcare recalls PrisMax System (Product Code 955724) due to software anomalies that may reset critical patient settings during treatment. Affected units include all serial numbers with specific GTIN.
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.
Baxter Healthcare is recalling its PrisMax System (Product Code 955724) because software issues can reset patient settings when using certain functions. This could lead to incorrect treatment parameters if the system reverts to default values without warning.
The system may reset critical patient settings (Gain/Loss Limit or Return Pressure Drop Limit) when specific functions are used. This happens without warning, potentially causing incorrect treatment parameters if the user restarts therapy.
Patients using the PrisMax System for medical therapy are affected. Healthcare providers managing these devices are most at risk of incorrect settings during treatment.
Check for the Product Code 955724 on the device. All serial numbers are affected, including units with GTIN 07332414126018.
Verify if the system resets patient settings when using the Same Patient function or changing patient weight/hematocrit.
No, only the specific Product Code 955724 with all serial numbers and GTIN 07332414126018 are affected.
The recall does not specify a remedy, so check with Baxter Healthcare for guidance on potential actions.
The recall states software anomalies may reset settings without warning, but no specific injury risk is mentioned.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0992-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0992-2022 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
