Dose IQ Safety Software used with Spectrum IQ Infusion Pump
FDA device recall Z-2165-2021 · posted 2021-08-11 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 61 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2021-07-07
- Date posted
- 2021-08-11
- Date terminated
- 2024-06-20
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectrum IQ Infusion System, Dose IQ Safety Software (K173084) | Baxter Healthcare Corporation | 2018-05-11 |