Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
GTIN 00085412498683, Software version v8.01.01, Serial Numbers
Products Sold
GTIN 00085412498683, Software version v8.01.01, Serial Numbers
Baxter Healthcare Corporation is recalling SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 due to A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Softw. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026