Critical RiskFDA Device

Baxter Healthcare Corporation: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Agency Publication Date: July 13, 2023

Affected Products

Product: SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

GTIN 00085412498683, Software version v8.01.01, Serial Numbers

Product: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92562

Status: Active

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 2 products (3306 units; 19861 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

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