FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
- Recall number
- Z-2110-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
- Status
- Terminated
- Initiated
- 2021-06-04
- Posted
- 2021-08-06
- Terminated
- 2024-09-25
- 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.
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K173084"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28