FDA (Devices) recall action 89823
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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 ret…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.
The PrisMax dialysis system has a software bug that silently reverts treatment parameters to default values without notifying operators, affecting 1,253 units worldwide.
The PrisMax System may revert custom treatment parameters to default values without notifying the operator when the Same Patient function is used. This could cause patients to receive unintended treatment settings.