PrisMax System, Product Code 955626
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is correcting the PrisMax System due to software problems that can cause treatment parameters to reset without user notification. When an operator enters custom values for the patient Gain/Loss Limit or Return Pressure Drop Limit and then uses the Same Patient function, the system reverts these values back to default settings instead of maintaining the entered values. While the interface displays the original values when treatment restarts, no alert warns the user that the change has occurred. The Return Pressure Drop Limit resets immediately upon selecting Same Patient, while the Gain/Loss Limit resets when patient weight or hematocrit is changed during treatment.
This correction affects 1,253 units of the PrisMax System (Product Code 955626) with all serial numbers distributed worldwide, including throughout the United States and numerous countries in the Americas, Europe, Asia-Pacific, and the Middle East. The record does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom. Quantity: 1253 units Lot/code info: GTIN 00085412639499, All Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.