The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reported: July 19, 2023 Initiated: June 15, 2023 #Z-2104-2023
Product Description
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 19861 units
- Distribution
- US Nationwide distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. Recalled by Baxter Healthcare Corporation. Units affected: 19861 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2023. Severity: Critical. Recall number: Z-2104-2023.
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