FDA-Device2021-08-18Class I
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Hazard
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.
Sold states
US Nationwide Distribution.
Affected count
61 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2021More Baxter Healthcare Corporation recalls
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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