Jul

2012

SIGMASpectrum Drug Library software Cl lll

Company:Sigma
Date of Enforcement Report 7/25/12
Class lll:

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. Recall Number Z-2030-2012

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.

RECALLING FIRM/MANUFACTURER
Sigma, Medina, NY on 4/23/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,048 CD’s

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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SIGMASpectrum Drug Library software Cl lll

Amy Sellers

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