Home / Recalls / Baxter Healthcare Corporation / Z-2104-2023

Z-2104-2023 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
19861 units

Product Description

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

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

UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers

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