Recall · FDA
Baxter Healthcare Corporation
Baxter Healthcare Corporation issued a Class II FDA recall (Z-0992-2022) initiated 2022-03-15: PrisMax System, Product Code 955724
| Company | Baxter Healthcare Corporation |
|---|---|
| Recall number | Z-0992-2022 |
| Classification | Class II |
| Status | Ongoing |
| Category | Devices |
| Initiated | 2022-03-15 |
| 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. |
FAQ
What did Baxter Healthcare Corporation recall?
PrisMax System, Product Code 955724
Why was Baxter Healthcare Corporation's product recalled?
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 wi…