SIGMA Spectrum Infusion Pump — Class I medical device recall Z-2103-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-07-19, distributed nationwide. A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ I
| Recall number | Z-2103-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-06-15 |
| Classified | 2023-07-13 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 3,306 units |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 00085412498683 |
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Reason for recall
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2103-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.