Z-2110-2021Class I

Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled...

Name: Z-2110-2021 Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled...
Creator: Baxter Healthcare Corporation
Published: 2021-06-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-06-04 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids on 2021-06-04. FDA classified it as Class I and gives the reason as "System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2110-2021
Classification: Class I
Status: Terminated
Initiated: 2021-06-04
Posted: 2021-08-06
Terminated: 2024-09-25
Recalling firm: Baxter Healthcare Corporation
Product: Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Product code: FRN Pump, Infusion
Reason for recall: System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Root cause tag: software
FDA root cause: Software design
Action: Baxter initiated the recall by letter on 06/04/2021. The letter described the problem and the hazard involved, and requested the consignee Baxter Technical Assistance in advance of making changes to your network or server infrastructure supporting the pumps or the Baxter Gateway, as indicated in Baxter's Gateway Server Installation Handoff document which customers receive upon installation. The firm is developing a software patch for all Spectrum IQ infusion pumps.
Quantity in commerce: 130135 units
Distribution: United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2110-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2110-2021	Class I	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-06

Product code FRN

K173084Class IISpectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation / cleared 2018-05-11

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)