FDA Recall: Infusion pumps may have an incorrect version of software

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 7/17/2025
Class: I

PRODUCT

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Recall Number:

Z-2095-2025

REASON:

Certain Spectrum infusion pumps may have an incorrect version of software.

RECALLING FIRM/MANUFACTURER:

Baxter Healthcare Corporation

VOLUME:

14 units

DISTRIBUTION:

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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IEC 29119-1 Software and System Testing

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