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U.S. Department of Health and Human Services

Class 3 Device Recall SIGMASpectrum

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 Class 3 Recall
SIGMASpectrum
see related information
Date Posted July 18, 2012
Recall Status1 Open
Recall Number Z-2030-2012
Recall Event ID 61691
Premarket Notification
510(K) Number
K042121 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information All versions
Recalling Firm/
Manufacturer
Sigma
711 Park Ave
Medina, New York 14103-1036
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 2,048 CD's
Distribution Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.
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