Jul

2023

FDA Recall: Increase in Reporting of False Occlusion Alarms

Allison Pate

News

fda, recall

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 07/13/2023
Class I

PRODUCT

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Recall Number:

Z-2103-2023

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Baxter Healthcare Corporation

VOLUME OF PRODUCT IN COMMERCE:

3306 units

DISTRIBUTION:

US Nationwide distribution.

About the author

Allison Pate

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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FDA Recall: Increase in Reporting of False Occlusion Alarms

Allison Pate

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