FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Dose IQ Safety Software used with Spectrum IQ Infusion Pump
- Recall number
- Z-2165-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Dose IQ Safety Software used with Spectrum IQ Infusion Pump
- Status
- Terminated
- Initiated
- 2021-07-07
- Posted
- 2021-08-11
- Terminated
- 2024-06-20
- Reason
- Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
- Root cause
- Software design
- Action
- The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2021. The letter explained the issue and provided a temporary workaround which can be implemented until the new software tool is ready for distribution.
- Quantity
- 61 units
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Software version: All libraries initially created with version 9.0.x
- 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