CLASS I ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report

Sigma Spectrum Infusion Pump, Product recalled by Baxter Healthcare

Baxter Healthcare is recalling Sigma Spectrum Infusion Pump, distributed nationwide in the US. The recall was initiated on 15 Jun 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 00085412498683, Software version v8.01.01, Serial Numbers

Quantity recalled3306 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2103-2023
FDA event ID: 92562
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 15 Jun 2023
FDA classified: 13 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

15 Jun 2023	Recall initiated by company
13 Jul 2023	Classified by FDA	+28 days
19 Jul 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 00085412498683, Software version v8.01.01, Serial Numbers

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92562

This product is part of a recall event; the main page for the event is The Spectrum IQ Infusion System with Dose IQ Safety recalled.

Reported	Class	Recall	Company	Reason	Where
19 Jul 2023	CLASS I	The Spectrum IQ Infusion System with Dose IQ Safety recalled	Baxter Healthcare	Device Malfunction	Nationwide

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All 573

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All 546

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9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide