FDA-Device2018-10-24Class II

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Baxter Healthcare Corporation
Hazard

If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.

Sold states
NJ
Affected count
354 units
Manufactured in
711 Park Ave, N/A, Medina, NY, United States
Products
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2019

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