Recall Z-2110-2021— Baxter Healthcare Corporation
Class I · Terminated
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-06-04, terminated 2024-09-25. It names one FDA 510(k) clearance: K173084. Product: Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.. Reason: System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-06-04
- Terminated
- 2024-09-25
- 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
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reason for recall
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.