Recall Z-2110-2021 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
| Date | Aug 6, 2021 (initiated Jun 4, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Baxter initiated the recall by letter on 06/04/2021. The letter described the problem and the hazard involved, and requested the consignee Baxter Technical Assistance in advance of making changes to your network or server infrastructure supporting the pumps or the Baxter Gateway, as indicated in Baxter's Gateway Server Installation Handoff document which customers receive upon installation. The firm is developing a software patch for all Spectrum IQ infusion pumps. |
| Quantity | 130135 units |
| Distribution | United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation, May 11, 2018 |