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U.S. Department of Health and Human Services

Class 1 Device Recall SIGMA Spectrum Infusion Pump

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  Class 1 Device Recall SIGMA Spectrum Infusion Pump see related information
Date Initiated by Firm June 15, 2023
Date Posted July 13, 2023
Recall Status1 Open3, Classified
Recall Number Z-2103-2023
Recall Event ID 92562
510(K)Number K230022  
Product Classification Pump, infusion - Product Code FRN
Product SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Code Information GTIN 00085412498683, Software version v8.01.01, Serial Numbers
Recalling Firm/
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
Manufacturer Reason
for Recall
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
FDA Determined
Cause 2
Under Investigation by firm
Action Customers were contacted via phone and email beginning on June 2, 2023. An Urgent Medical Device communication was sent to all affected customers on June 15, 2023, via U.S.P.S., first class mail. The notice explained the problem, the risk involved, and requested the following: "Actions to be taken by Customers: 1. Operators may continue to use Spectrum V8 and Spectrum IQ pumps by following on-screen instructions, or the infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator s Manual. An electronic copy of the Operator s Manual can be accessed at https://service.baxter.com/tsportal/. Please note that false upstream occlusion alarms can occur at a higher rate until the software reversion is completed. If you are unable to resolve an upstream occlusion alarm, unload and reload the set. 2. A Baxter representative will contact your facility to determine the correction plan and schedule the software reversion. The representative will work with you to determine a list of affected serial numbers at your facility. Please note you will be receiving this software reversion from Baxter at no charge." "Further information and support: If you have additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-356-3454 (choose option 3) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."
Quantity in Commerce 3306 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Baxter Healthcare Corporation