FDA-Device2012-07-25Class III
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Sigma
Hazard
Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
Sold states
Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Affected count
2,048 CD's
Manufactured in
711 Park Ave, Medina, NY, United States
Products
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2030-2012Don't want to check this manually?
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