Recall – Infusion pump software error may occur during programming

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

PRODUCT

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

REASON

There is a potential software error during programming.

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

9,353 devices

DISTRIBUTION

U.S. Nationwide and International

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IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

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