The Spectrum IQ Infusion System with Dose IQ Safety recall: Software Issue
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Why was The Spectrum IQ Infusion System with Dose IQ Safety 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers
- Product
- The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 19861 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 19, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)