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Recall Observatory FDA recall evidence

Device product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

Z-0714-2021

November 23, 2020

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 86758
Status
Ongoing
Classification
Class II
Quantity
140,006 devices
Official record key
device-enforcement:Z-0714-2021

Official wording

Reason: There is a potential software error during programming.

Code information: Product Code 35700BAX2, GTIN 00085412498683

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error