Sigma: Medical Device Recall in 2012 - (Recall #: Z-2030-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: April 23, 2012

Date Posted: July 25, 2012

Recall Number: Z-2030-2012

Event ID: 61691

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,048 CD's

Code Information:

All versions

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated