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Recall Observatory FDA recall evidence

Device product

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

Z-2110-2021

June 04, 2021

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 88073
Status
Terminated
Classification
Class I
Quantity
130135 units
Official record key
device-enforcement:Z-2110-2021

Official wording

Reason: 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.

Code information: All Serial Numbers

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.