Baxter recalls Spectrum IQ Infusion Systems with v9.02.01 software due to increased false occlusion alarms after specific updates. Affected units may need reconfiguration to prevent unnecessary alerts.
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.
Baxter is recalling infusion pumps with software version v9.02.01 that have increased false alarms. This could cause unnecessary interruptions during medical treatments if not addressed.
False upstream occlusion alarms can trigger unnecessary pauses in medication delivery. This happens after specific software updates (v8.01.01 and v9.02.01) that increase error signals.
Patients using Baxter's Spectrum IQ Infusion Systems with software version v9.02.01 are affected. Healthcare providers managing these devices are most at risk of disruptions.
Check for product code 3570009, software version v9.02.01, and serial numbers on the device. The recall covers all units sold with these specifications.
Verify the software version on your device; if it's v9.02.01, it's affected.
Baxter issued a correction for false upstream occlusion alarms after software updates v8.01.01 and v9.02.01.
No action is needed if your software version is not v9.02.01.
Check the product code (3570009), software version (v9.02.01), and serial number on your device.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2104-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-2104-2023 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
