Baxter recalls SIGMA Spectrum Infusion Pumps with software v8.01.01 or v9.02.01 due to increased false occlusion alarms. Affected units may need software correction.
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 certain SIGMA Spectrum Infusion Pumps that have software versions v8.01.01 or v9.02.01. These pumps may give false alarms about blockages, which could lead to unnecessary treatment interruptions for patients.
The pumps may trigger false alarms about blockages in the infusion line after software updates. This can cause unnecessary pauses in medication delivery, potentially delaying treatment for patients.
Patients using these infusion pumps with specific software versions are affected. Healthcare providers managing these pumps are most at risk of treatment disruptions.
Check for product code 35700BAX2, software version v8.01.01 or v9.02.01, and serial numbers on the pump. These pumps were sold with the specified software versions.
Look for software version v8.01.01 or v9.02.01 on the pump's display or documentation.
Baxter issued a recall because these pumps have increased false occlusion alarms after software updates to versions v8.01.01 and v9.02.01.
No, the recall does not require immediate stoppage. Users should check the software version and contact Baxter if needed.
Check the software version. If it's v8.01.01 or v9.02.01, contact Baxter Healthcare for software correction.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2103-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-2103-2023 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.
