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FDA issues early alert for Baxter's Spectrum infusion pump
The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ issue with certain Baxter Sigma Spectrum and Spectrum IQ infusion pumps.
The agency’s notice highlights that Baxter has issued a letter to affected customers, recommending its Sigma Spectrum Infusion System V6 platform and Spectrum IQ Infusion System with Dose IQ Safety Software either be removed from sale or no longer used. Baxter said the Spectrum infusion pumps are being recalled due to the potential of missing motor mounting screws. Initiated in November 2024, the pilot is designed to provide early alerts on potentially high-risk device removals or corrections related to devices spanning medical fields, including cardiovascular, gastrorenal, general hospital, obstetrics and gynaecology, and urology.
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