Sigma Spectrum Infusion Pump Warning Issued Due to Incorrect Software: FDA

FDA issues early alerts for certain Baxter, Abiomed products

The Food and Drug Administration has issued early alerts for certain Spectrum infusion pumps from Baxter and Abiomed Automated Impella Controllers. The agency said the affected infusion pumps may have an incorrect version of software, while the Abiomed product may not detect an Impella pump when connected.

Early Alert: Infusion Pump Software Issue from Baxter - TechNation

The U.S. Food and Drug Administration is aware that Baxter has issued a letter to affected customers recommending certain Spectrum Infusion Pumps be removed from where they are used or sold. Baxter has stated that certain Spectrum Infusion Pumps may have an incorrect version of software installed. This could result in a delay or interruption

Sigma Spectrum Infusion Pump Warning Issued Due to Incorrect Software: FDA

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