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Baxter Healthcare Corporation recalls The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Recalled July 19, 2023 · FDA recall Z-2104-2023 · 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
19861 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
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →