Z-2104-2023Class I

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Name: Z-2104-2023 The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Creator: Baxter Healthcare Corporation
Published: 2023-06-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-06-15 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 on 2023-06-15. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2104-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-06-15
Posted: 2023-07-13
Recalling firm: Baxter Healthcare Corporation
Product: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA root cause: 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: 19861 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2104-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-13
Z-2104-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-13

Product code FRN

K230041Class IISpectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation / cleared 2023-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)