FDA-Device2023-07-19Class I
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
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
3306 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2023Don't want to check this manually?
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