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Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Recalled July 19, 2023 · FDA recall Z-2103-2023 · Baxter Healthcare
Hazard
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. · FDA Class I
Units
3306 units
Sold at
US Nationwide distribution.
Description
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.
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →