Recall Z-2104-2023— Baxter Healthcare Corporation
Class I · Ongoing
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-06-15. It names one FDA 510(k) clearance: K230041. Product: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. Reason: 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-06-15
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.