Baxter Healthcare recalls PrisMax System with product codes 955558, 955627, 955701 due to software anomalies that may reset patient settings during therapy. Affected units may require correction to prevent incorrect treatment values.
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 three specific PrisMax System product codes because software issues can reset patient settings when using certain functions. This could lead to incorrect treatment values being used during therapy sessions.
The software may reset patient settings like Gain/Loss Limit or Return Pressure Drop Limit when specific functions are used. This could cause incorrect treatment values to be applied during therapy sessions without warning to the user.
Patients using the PrisMax System with product codes 955558, 955627, or 955701 are affected. Healthcare providers who use this system for medical treatments are most at risk.
Check for product codes 955558, 955627, or 955701 on the device. The system may also have unique identifiers (UDIs) listed in the recall notice.
Identify the product code on your PrisMax System to see if it matches 955558, 955627, or 955701.
The software may reset patient settings like Gain/Loss Limit or Return Pressure Drop Limit when specific functions are used, which could lead to incorrect treatment values being applied during therapy sessions.
The recall record does not specify a remedy, so you should check with Baxter Healthcare for further instructions.
Check for product codes 955558, 955627, or 955701 on the device. The system may also have unique identifiers (UDIs) listed in the recall notice.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0993-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0993-2022 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.
