Baxter Healthcare recalls PrisMax System (Product Code 955626) due to software issues that may reset critical patient settings during treatment. Affected units include all serial numbers with GTIN 00085412639499.
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 with product code 955626 because software anomalies can reset patient settings during treatment. This could lead to incorrect therapy settings if the user changes specific limits and then uses the Same Patient function.
The software may reset critical patient settings (Gain/Loss Limit or Return Pressure Drop Limit) when the Same Patient function is used after entering non-default values. This could cause incorrect therapy settings if the user restarts treatment without noticing the reset.
Patients using the PrisMax System for medical therapy are affected. Healthcare providers who operate the system are most at risk due to potential incorrect settings during treatment.
Check for the PrisMax System with product code 955626 and GTIN 00085412639499. All serial numbers are affected, so verify the product code and GTIN on the device.
Verify the product code on your PrisMax System is 955626 and the GTIN is 00085412639499.
Yes, if your PrisMax System has product code 955626 and GTIN 00085412639499, it is affected.
The recall does not specify a remedy, so contact Baxter Healthcare directly for guidance.
The recall states software anomalies may reset settings, 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-0991-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0991-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
