FDAClass IAugust 18, 2021

Dose IQ Safety Software used with Spectrum IQ Infusion recall: Software Issue

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Why was Dose IQ Safety Software used with Spectrum IQ Infusion recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software version: All libraries initially created with version 9.0.x

Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Recalling firm
Baxter Healthcare Corporation
Quantity
61 units
Distribution
US Nationwide Distribution.
Recall date
August 18, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls