# FDA recall Z-2103-2023

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2023-06-15.

## Product

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

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2103-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-15
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2023

## Citation

> AI Analytics. FDA recall Z-2103-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2103-2023. Source: US FDA. Licensed CC0.

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