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Terminated

Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

FDA Recall Z-2110-2021 · Posted 2021-08-06

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2021-06-04
Date Terminated2024-09-25
Product Quantity130135 units

Reason for Recall

System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.

Firm Action

Baxter initiated the recall by letter on 06/04/2021. The letter described the problem and the hazard involved, and requested the consignee Baxter Technical Assistance in advance of making changes to your network or server infrastructure supporting the pumps or the Baxter Gateway, as indicated in Baxter's Gateway Server Installation Handoff document which customers receive upon installation. The firm is developing a software patch for all Spectrum IQ infusion pumps.

Root Cause

Software design

Distribution Pattern

United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018-05-11

Official Source

View FDA Recall →

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

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