SIGMA Spectrum Infusion Pump recall: Software Issue
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Why was SIGMA Spectrum Infusion Pump 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?
GTIN 00085412498683, Software version v8.01.01, Serial Numbers
- Product
- SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 3306 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 19, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)