medical Class I Updated 2023-07-19

Baxter Healthcare Corporation recalls The Spectrum IQ Infusion System with Dose IQ Safety Software

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers
View official government recall

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