Official recall record

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

US FDA — Medical Devices · 2023-06-15 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-06-15
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 00085412610900
Brand on record: Baxter Healthcare Corporation

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-07-14 · US FDA — Medical Devices
Spectrum IQ Infusion Pump, Product Code 3570009
2024-10-02 · US FDA — Medical Devices
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
2018-09-18 · US FDA — Medical Devices
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
2021-12-29 · US FDA — Medical Devices
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
2026-01-13 · US FDA — Medical Devices
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Desc

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All 48 official recall notices naming Baxter Healthcare Corporation on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.