FDA (Devices) recall action 92562
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.