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.
FDA Recall Z-2030-2012 · Posted 2012-07-18
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Recalling FirmSigma
Recall StatusTerminated
Product CodeFRN
Date Initiated2012-04-23
Date Terminated2018-07-05
Product Quantity2,048 CD's
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.
Firm Action
Sigma sent an Urgent: Customer Safety Alert dated April 23, 2012 via UPS delivery to all consignees requesting both acknowledgement of notification and confirmation that recommended actions have been taken. Customers are asked to follow the instructions contained in the recall letter. Customers with questions may contact the firm at 800-356-3454 ext 300.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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