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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Baxter Healthcare Corporation: 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

Agency Publication Date: April 22, 2022
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Affected Products

Product: PrisMax System, Product Code 955626

GTIN 00085412639499, All Serial Numbers

Product: PrisMax System, Product Code 955724

GTIN 07332414126018, All Serial Numbers

Product: PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

a) 955558, UDI 07332414124359, b) 955627, UDI 07332414124700, c) 955701, UDI 07332414125844, All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89823
Status: Active
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 3 products (1253 units; 296 units; 3513 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.