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Recall Observatory FDA recall evidence

Device product

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Z-2104-2023

June 15, 2023

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 92562
Status
Ongoing
Classification
Class I
Quantity
19861 units
Official record key
device-enforcement:Z-2104-2023

Official wording

Reason: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Code information: UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.