Recall – Infusion pump software error may occur during programming

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 12/30/2020
Class II


Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) – Product Usage: intended to be used for the controlled administration of fluids.

Recall Number: Z-0712-2021


There is a potential software error during programming.


Baxter Healthcare Corporation on 11/23/2020. Voluntary:  Firm Initiated recall is ongoing.


9,353 devices


U.S. Nationwide and International

62304 Software Training Course – February 23-25, 2021

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