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Terminated

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

FDA Recall Z-2165-2021 · Posted 2021-08-11

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2021-07-07
Date Terminated2024-06-20
Product Quantity61 units

Reason for Recall

Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.

Firm Action

The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2021. The letter explained the issue and provided a temporary workaround which can be implemented until the new software tool is ready for distribution.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution.

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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