Z-2165-2021Class I

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Name: Z-2165-2021 Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Creator: Baxter Healthcare Corporation
Published: 2021-07-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-07-07 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Dose IQ Safety Software used with Spectrum IQ Infusion Pump on 2021-07-07. FDA classified it as Class I and gives the reason as "Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the 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-2165-2021
Classification: Class I
Status: Terminated
Initiated: 2021-07-07
Posted: 2021-08-11
Terminated: 2024-06-20
Recalling firm: Baxter Healthcare Corporation
Product: Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Product code: FRN Pump, Infusion
Reason for recall: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2021. The letter explained the issue and provided a temporary workaround which can be implemented until the new software tool is ready for distribution.
Quantity in commerce: 61 units
Distribution: US Nationwide Distribution.
Product codes and lots: Software version: All libraries initially created with version 9.0.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2165-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2165-2021	Class I	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-11

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)