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Recall Observatory FDA recall evidence

Device product

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.

Z-2030-2012

April 23, 2012

Class III

Product summary

Firm
Sigma
Event
Event 61691
Status
Terminated
Classification
Class III
Quantity
2,048 CD's
Official record key
device-enforcement:Z-2030-2012

Official wording

Reason: 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.

Code information: All versions

Distribution pattern: Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software associated with the SIGMA Spectrum Infusion Pump System because it may result in