medical Class I Updated 2023-07-19

Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Recalled Product

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2


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: GTIN 00085412498683, Software version v8.01.01, Serial Numbers
View official government recall

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