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Open, Classified

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

FDA Recall Z-0713-2021 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2020-11-23
Product Quantity293,926 devices

Reason for Recall

There is a potential software error during programming.

Firm Action

A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042121SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYSigma Intl. · 2004-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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