FDA Device recall Z-0992-2022

PrisMax System, Product Code 955724

• FDA Device
• Class II
• ongoing
• Published 2022-05-04

On 2022-05-04 the FDA classified a Class II recall of PrisMax System, Product Code 955724 by Baxter Healthcare, citing 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 Lim….

Read the official FDA Device notice

Product

PrisMax System, Product Code 955724

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2022%22

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