FDA Device recall Z-2165-2021
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
- FDA Device
- Class I
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class I recall of Dose IQ Safety Software used with Spectrum IQ Infusion Pump by Baxter Healthcare, citing 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 I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2165-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-07-07 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
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.
Identifiers
| code_info | Software version: All libraries initially created with version 9.0.x |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2165-2021%22
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