Home / Recalls / Baxter Healthcare Corporation / Z-2103-2023

Z-2103-2023 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 19, 2023
Initiation Date
June 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3306 units

Product Description

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

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.

Distribution Pattern

US Nationwide distribution.

Code Information

GTIN 00085412498683, Software version v8.01.01, Serial Numbers

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