FDA-Device2023-07-19Class I
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Baxter Healthcare Corporation
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.
Sold states
US Nationwide distribution.
Affected count
19861 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2104-2023Don't want to check this manually?
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