Recall Z-2165-2021 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
| Date | Aug 11, 2021 (initiated Jul 7, 2021) |
| Status | Terminated |
| 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. |
| 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 |