PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has issued a correction for the PrisMax System (product codes 955558, 955627, and 955701) due to software problems that affect how the device handles patient treatment settings. When an operator enters non-default values for the patient Gain/Loss Limit or Return Pressure Drop Limit (RDL) and then uses the Same Patient function, the system resets these values back to the defaults instead of maintaining the entered values. Although the interface displays the original values when treatment restarts, the system does not alert the user that these changes have occurred. The RDL value resets immediately upon selecting Same Patient, while the Gain/Loss Limit value resets when patient weight or hematocrit is changed during treatment.
This correction affects 3,513 units of the PrisMax System distributed worldwide, including across the United States, Canada, Mexico, and numerous countries in Central America, South America, Asia, Australia, the Middle East, and Europe. The recall document does not specify a remedy or required action for consumers who have this equipment.
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: 3513 units Lot/code info: a) 955558, UDI 07332414124359, b) 955627, UDI 07332414124700, c) 955701, UDI 07332414125844, All Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.