Baxter Healthcare Corporation: SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Hazard

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.

Details from the source

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. Quantity: 3306 units Lot/code info: GTIN 00085412498683, Software version v8.01.01, Serial Numbers

UPC codes

00085412498683

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.